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PMA Final Decisions for November 2012

Wed, 01/09/2013 - 12:00am
U.S. Food & Drug Administration

Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis.

A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available.

PMA Original Approvals

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P100022
11/14/12
Zilver PTX Drug-Eluting Peripheral Stent (6- 8 mm diameter; 20- 80 mm length) Cook Incorporated
Bloomington, IN
47402
Approval for the Zilver PTX Drug-Eluting Peripheral Stent. This device is indicated for improving luminal diameter for the treatment of de novo or restenotic symptomatic lesions in native vascular disease of the above-the-knee femoropopliteal arteries having reference vessel diameters from 4 mm to 9 mm and total lesion lengths up to 140 mm per limb and 280 mm per patient.
P100047
11/20/12
HeartWare® Ventricular Assist System HeartWare, Inc.
Miami Lakes, FL
33014
Approval for the HeartWare® Ventricular Assist System (VAS). This device is indicated for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The Heart Ware® VAS is designed for in-hospital and out-of-hospital settings, including transportation via fixed wing aircraft or helicopter.
P120002
11/7/12
 
S.M.A.R.T.® CONTROL® and S.M.A.R.T.® Vascular Stent Systems Cordis Corporation
Miami Lakes, FL
33014
Approval for the S.M.A.R.T.® CONTROL® and S.M.A.R.T.® Vascular Stent Systems. This device is indicated for use to improve luminal diameter in the treatment of patients with de novo or restenotic native lesion(s) of the superficial femoral artery and/or proximal popliteal artery with total length up to 150 mm and with a reference vessel diameter ranging from 4 mm to 7 mm.
P120008
11/28/12
ARCHITECT AFP Assay, ARCHITECT AFP Calibrators and ARCHITECT AFP Controls Abbott Laboratories
Abbott Park, IL
60064
Approval for the ARCHITECT AFP Assay, ARCHITECT AFP Calibrators and ARCHITECT AFP Controls. This device is indicated for:
The ARCHITECT AFP assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of alpha-fetoprotein (AFP) in:
1) Human serum or plasma to aid in monitoring disease progression during the course of disease and treatment of patients with nonseminomatous testicular cancer; and
2) Human serum, plasma, and amniotic fluid at 15 to 21 weeks gestation to aid in the detection of fetal open neural tube defects (NTD). Test results when used in conjunction with ultrasonography or amniography are a safe and effective aid in the detection of fetal open NTD. The ARCHITECT AFP Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of alpha-fetoprotein (AFP) in human serum, plasma, and amniotic fluid. The performance of the ARCHITECT AFP Calibrators has not been established with any other AFP assays. The ARCHITECT AFP Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System when used for the quantitative determination of alpha-fetoprotein (AFP) in human serum, plasma, and amniotic fluid. The performance of the ARCHITECT AFP controls has not been established with any other AFP assays.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P810002/S078
11/1/12
Real-Time
SJM Regent Mechanical Heart Valve, Mechanical Heart Valve SJM Masters Series (PTFE), Mechanical Heart Valve SJM Masters Series (Polyester) Mechanical HV SJM Masters Series Coated Aortic Valve Graft, SJM Masters HP Valved Graft w/Gelweave Valsalva Tech St. Jude Medical
St. Paul, MN
55117
Approval to update the Instructions for Use (IFU), St. Jude Medical (SJM) internet, and any other applicable device labeling to include the new magnetic resonance imaging (MRI) testing information to enhance the safe use of the device when undergoing MRI.
P830055/S127
11/19/12
Real-Time
LCS® Total Knee System DePuy Orthopaedics, Inc.
Warsaw, IN
46581
Approval for the addition of mobile bearing Attune PS RP tibial inserts that are modifications to the previously approved LCS Complete/PFC Sigma RP/Attune RP tibial inserts, and are intended to be used with the cleared Attune Total Knee System femoral, patella, and components. The supplement also requests the addition of a 9mm tibial insert thickness for all sizes (I - I 0) of Attune CR RP tibial inserts. The new inserts are manufactured from the antioxidant polyethylene material (AOX™). The device, as modified, will be marketed under the trade name Attune™ and is indicated for use in total knee replacement in patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.
P830055/S128
11/19/12
Special
LCS® Total Knee System DePuy Orthopaedics, Inc.
Warsaw, IN
46581
Approval for an additional rinse step being implemented in the manufacturing process for the MBT Cemented and Porous Trays and the Attune RP Tibial Base.
P850048/S028
11/19/12
Special
Access Hybritech PSA reagents on the Access Immunoassay Systems Beckman Coulter, Inc.
Chaska, MN
55318
Approval for the addition of information to the Manufacturing procedures of the instrument (specifically, the instructions for application of the adhesive to the mixer pulley assembly and the implementation of a verification test to ensure the mixer pulley assemblies pass the torque specification.)
P860003/S066
11/9/12
Real-Time
THERAKOS® UVAR XTS® Photopheresis System Procedural Kit THERAKOS, Inc.
Raritan, NJ
08869
Approval for the addition of 8 ribs to the neck of the centrifuge bowls used in the device and for the accompanying packaging changes.
P860003/S067
11/19/12
Real-Time
THERAKOS® CELLEX® Photopheresis System THERAKOS, Inc.
Raritan, NJ
08869
Approval for some minor changes intended to reduce specular reflection of the KT8L sensor's laser beam and improve its optic path (e.g., removal of glass port, removal of resistor, and addition of gasket).
P880006/S082
11/7/12
Real-Time
Sensolog, Dialog and Regency Family of Pacemakers St. Jude Medical
Sylmar, CA
91342
Approval for software changes to the Merlin PCS Programmer.
P880086/S223
11/7/12
Real-Time
Affinity, Integrity, Victory, Zephyr, and Accent Family of Pacemakers St. Jude Medical
Sylmar, CA
91342
Approval for software changes to the Merlin PCS Programmer.
P900060/S050
11/5/12
135-Day
Carbomedics Prosthetic Heart Valve Sorin Group USA, Inc.
Arvada, CO
80004
Approval for addition of an alternate supplier for manufacturing of the graphite substrate of valve leaflets.
P910023/S302
11/7/12
Real-Time
Cadence and Current Family of ICDs St. Jude Medical
Sylmar, CA
91342
Approval for software changes to the Merlin PCS Programmer.
P930027/S015
11/8/12
135-Day
IMMULITE PSA Assay Siemens Medical Solutions Diagnostics
East Walpole, MA
02032
Approval for eliminating the test redundancy by using only the BioRad Lyphocheck Immunoassay Plus controls in in-process component testing, post-fill testing and final kit combination testing for the assessment of IMMULITE AFP, Free PSA, and PSA/3 rd Generation PSA assay performance.
P950024/S040
11/27/12
180-Day
CapSure Epi Epicardial Lead Medtronic, Inc.
Mounds View, MN
55112
Approval to add Model 4965 post-approval study results to the device labeling.
P950024/S044
11/27/12
180-Day
CapSure Epi Epicardial Lead Medtronic, Inc.
Mounds View, MN
55112
Approval to add Model 4968 post-approval study results to the device labeling.
P950032/S069
11/20/12
Real-Time
Apligraf (Graftskin) Organogenesis, Incorporated
Canton, MA
02021
Approval for the introduction of Human Epidermal Keratinocyte cell strain 200 (HEP 200) into the manufacture of the device.
P960040/S266
11/14/12
135-Day
Incepta, Energen, Punctua, Teligen,
Confient ICDs
Boston Scientific Corporation
St. Paul, MN
55112
Approval for the addition of an automated vision system during seal plug inspection.
P960040/S270
11/30/12
180-Day
Incepta, Energen, Punctua and Teligen Implantable Cardioverter Defibrillator Boston Scientific Corporation
St. Paul, MN
55112
Approval for software, firmware, and hardware enhancements and modifications to the INCEPTA, ENERGEN, PUNCTUA, COGNIS, and TELIGEN devices.
D970003/S137
11/14/12
135-Day
Advantio, Ingenio, Altrua Pacemakers Boston Scientific Corporation
St. Paul, MN
55112
Approval for the addition of an automated vision system during seal plug inspection.
P970004/S141
11/1/12
180-Day
Interstim Therapy Medtronic Vascular
Minneapolis, MN
55432
Approval for the post-approval study protocol.
P970013/S051
11/7/12
Real-Time
Microny Family of Pacemakers St. Jude Medical
Sylmar, CA
91342
Approval for software changes to the Merlin PCS Programmer.
P970018/S025
11/8/12
135-Day
BD PrepStain System TriPath Imaging
Durham, NC
27703
Approval for a supplier change to the raw microsope slide, a critical component in the device.
P970038/S017
11/19/12
Special
Access Hybritech Free reagents on the Access Immunoassay Systems Beckman Coulter, Inc.
Chaska, MN
55318
Approval for the addition of information to the Manufacturing procedures of the instrument (specifically, the instructions for application of the adhesive to the mixer pulley assembly and the implementation of a verification test to ensure the mixer pulley assemblies pass the torque specification.)
P970051/S097
11/9/12
Real-Time
Nucleus® Cochlear™ Implant System Cochlear Americas
Centennial, CO
80111
Approval to introduce a remote control (CR120) for use with the Nucleus 5 (model CP810) sound processor for intraoperative use to conduct impedance and AutoNRT, measurements that are commonly used during cochlear implant surgery to indicate that the electrodes are functioning and are stimulating nerve tissue.
P980016/S384
11/2/12
Real-Time
Entrust, Intrinsic, Marquis, Onyx, Secura, Gem, Maximo, Protecta and Virtuoso Medtronic, Inc.
Mounds View, MN
55112
Approval for an update to the raw material of the capacitors used in the high voltage delivery circuitry.
P980022/S124
11/16/12
Real-Time
iPro2 Continuous Glucose Monitoring (COM) System Medtronic MiniMed
Northridge, CA
91325
Approval for software modifications to the CareLink iPro Therapy Management Software (MMT-7340) from version 1.4 to version 1.5A. The CareLink iPro Therapy Management Software (MMT-7340) is a component of the iPro2 Professional CGM System (MMT-7745).
P980041/S018
11/19/12
Special
Access Hybritech AFP reagents on the Access Immunoassay Systems Beckman Coulter, Inc.
Chaska, MN
55318
Approval for the addition of information to the Manufacturing procedures of the instrument (specifically, the instructions for application of the adhesive to the mixer pulley assembly and the implementation of a verification test to ensure the mixer pulley assemblies pass the torque specification.)
P990038/S017
11/30/12
Special
ETI-MAK-2 PLUS Assay DiaSorin, Inc.
Stillwater, MN
55082
Approval for a change to improve the sampling plan in the Quality Control Method for the incoming raw material microwell plates.
P990041/S016
11/30/12
Special
ETI-AB-EBK Assay DiaSorin, Inc.
Stillwater, MN
55082
Approval for a change to improve the sampling plan in the Quality Control Method for the incoming raw material microwell plates.
P990042/S013
11/30/12
Special
ETI-AB-AUK Plus Assay DiaSorin, Inc.
Stillwater, MN
55082
Approval for a change to improve the sampling plan in the Quality Control Method for the incoming raw material microwell plates.
P990043/S017
11/30/12
Special
ETI-EBK PLUS Assay DiaSorin, Inc.
Stillwater, MN
55082
Approval for a change to improve the sampling plan in the Quality Control Method for the incoming raw material microwell plates.
P990044/S014
11/30/12
Special
ETI-CORE-IGMK PLUS Assay DiaSorin, Inc.
Stillwater, MN
55082
Approval for a change to improve the sampling plan in the Quality Control Method for the incoming raw material microwell plates.
P990045/S014
11/30/12
Special
ETI-AB-COREK PLUS Assay DiaSorin, Inc.
Stillwater, MN
55082
Approval for a change to improve the sampling plan in the Quality Control Method for the incoming raw material microwell plates.
P990071/S020
11/20/12
Real-Time
CoolFlow Irrigation Pump Biosense Webster, Inc.
Diamond Bar, CA
91765
Approval for software and hardware modifications implemented to make the device compliant to IEC 60601-1 3 rd Edition.
P990081/S014
11/14/12
Real-Time
PATHWAY Anti-HER-2/neu ( 4B5) Rabbit Monoclonal Primary Antibody Ventana Medical Systems, Inc.
Tucson, AZ
85755
Approval for implementing a change to the Ventana regent dispenser seal for the Benchmark automated staining instruments.
P000008/S029
11/9/12
180-Day
LAP-BAND Adjustable Gastric Banding (LAGB) System Allergan, Inc.
Goleta, CA
93117
Approval of the post-approval study protocol.
P000013/S011
11/2/12
180-Day
Trident Ceramic-on-Ceramic Acetabular System Howmedica Osteonics Corporation
Mahwah, NJ
07430
Approval for labeling updates incorporating results of the completed post-approval study.
P000025/S058
11/21/12
180-Day
MED-EL COMBI 40+ Cochlear Implant System and
Mi1000 MED-EL CONCERT PIN Cochlear Implant.
MED-EL Corporation
Durham, NC
27713
Approval for the Mi1000 MED-EL CONCERT PIN cochlear implant.
P000025/S064
11/1/12
Real-Time
MED-EL COMBI 40+ Cochlear Implant System, MED-EL CONCERT Implant
 
MED-EL Corporation
Durham, NC
27713
Approval for a minor design change to the stimulator housing component of the Mi1000 MED-EL CONCERT implant that is intended to correct an error of dimensional tolerance of the housing components used in the manufacturing of the devices.
P000053/S046
11/13/12
Real-Time
AMS 800™ Urinary Control System American Medical Systems, Inc.
Minnetonka, MN
55343
Approval for minor design change to the Pump Shell Interface tolerances.
P010007/S009
11/8/12
135-Day
IMMULITE AFP Assay Siemens Medical Solutions Diagnostics
East Walpole, MA
02032
Approval for eliminating the test redundancy by using only the BioRad Lyphocheck Immunoassay Plus controls in in-process component testing, post-fill testing and final kit combination testing for the assessment of IMMULITE AFP, Free PSA, and PSA/3 rd Generation PSA assay performance.
P010012/S296
11/14/12
135-Day
Incepta, Energen, Punctua, Cognis,
Livian CRT-Ds
Boston Scientific Corporation
St. Paul, MN
55112
Approval for the addition of an automated vision system during seal plug inspection.
P010012/S300
11/30/12
180-Day
Incepta, Energen, Punctua and Cognis Cardiac Resynchronization Therapy-Defibrillator Boston Scientific Corporation
St. Paul, MN
55112
Approval for software, firmware, and hardware enhancements and modifications to the INCEPTA, ENERGEN, PUNCTUA, COGNIS, and TELIGEN devices.
P010013/S045
11/15/12
Real-Time
NovaSure Impedance Controlled Endometrial Ablation System Hologic, Inc.
Malborough, MA
01752
Approval for a change to fittings in the suction and vacuum feedback lines and minor labeling changes.
P010030/S031
11/2/12
180-Day
LifeVest Wearable Defibrillator Zoll Lifecor Corporation
Pittsburgh, PA
15238
Approval for several hardware design changes and a software driver upate.
P010031/S336
11/2/12
Real-Time
Consulta, Maximo II, Concerto and Insync Medtronic, Inc.
Mounds View, MN
55112
Approval for an update to the raw material of the capacitors used in the high voltage delivery circuitry.
P010033/S020
11/15/12
180-Day
QuantiFERON® Gold In-Tube Cellestis Incorporated Valencia, CA
91355
Approval for a change in the formulation of the Wash Buffer 20X Concentrate.
P010038/S016
11/9/12
180-Day
SecondLook DigitalV7.2 CAD iCAD, Inc.
Nashua, NH
03062
Approval for the SecondLook Digital V7.2 CAD for use with the Philips MicroDose full-field digital mammography (FFDM) system.
P020004/S072
11/7/12
135-Day
GORE EXCLUDER AAA Endoprosthesis W.L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Approval for use of an alternate PTFE resin.
P020004/S074
11/20/12
180-Day
GORE® EXCLUDER® AAA Endoprosthesis W.L. Gore & Associates, Inc.
Phoenix, AZ
85085
Approval for the additions of the 35 mm Trunk-Ipsilateral Leg and 36 mm Aortic Extender components to the GORE EXCLUDER AAA Endoprosthesis product portfolio.
P020004/S075
11/20/12
Real-Time
GORE® EXCLUDER® AAA Endoprosthesis W.L. Gore & Associates, Inc.
Phoenix, AZ
85085
Approval for the modification of the delivery system for the following device components of the GORE EXCLUDER AAA Endoprosthesis on the SIM-PULL (original) and C3 (EMDS) catheters in order to lower their delivery profiles as outlined below:
1) 16, 18 and 20 mm Contralateral Legs from 18 Fr to 12 Fr; 2) 23 mm Contralateral Leg from 18 Fr to 14 Fr;
3) 27 mm Colateral Leg from 18 Fr to 15 Fr; 4) 23, 26, 28.5 mm Aortic Extenders from 18 Fr to 16 Fr;
5) 32 mm Aortic Extender from 20 Fr to 17 Fr; 6) 31 mm Trunk-Ipsilateral Leg with SIM-PULL delivery system from 20 Fr to 18 Fr; and
7) 31 mm Trunk-Ipsilateral Leg with C3 delivery system from 20 Fr to 18 Fr.
P020055/S004
11/14/12
Real-Time
PATHWAY Anti-c-KIT (9.7) Rabbit Monoclonal Primary Antibody Ventana Medical Systems, Inc.
Tucson, AZ
85755
Approval for implementing a change to the Ventana regent dispenser seal for the Benchmark automated staining instruments.
P030005/S085
11/14/12
135-Day
Invive CRT-Ps Boston Scientific Corporation
St. Paul, MN
55112
Approval for the addition of an automated vision system during seal plug inspection.
P030017/S144
11/16/12
Real-Time
Implantable Pulse Generator (IPG) Boston Scientific Neuromodulation (BSN)
Valencia, CA
91355
Approval for a material change or the Implantable Pulse Generator (IPG) antenna coil from gold to copper.
P030017/S145
11/19/12
Real-Time
Precision Spinal Cord Stimulator (SCS) Boston Scientific Neuromodulation (BSN)
Valencia, CA
91355
Approval for an update to the Clinician Programmer computer used with the device. A tablet computer from ASUS, model EEE Slate B121, will be used to replace the current Clinician Programmer (CP), a Toshiba model M400 laptop computer.
P030035/S101
11/7/12
Real-Time
Frontier, Frontier II, and Anthem Family of CRT-Ps St. Jude Medical
Sylmar, CA
91342
Approval for software changes to the Merlin PCS Programmer.
P030036/S040
11/2/12
180-Day
SelectSecure Lead Medtronic CRDM
Mounds View, MN
55112
Approval for improvements to the SelectSecure Model 3830 lead drug methods and specifications.
P030052/S010
11/13/12
Special
UroVysion Bladder Cancer Kit Abbott Molecular, Inc.
Des Plaines, IL
60018
Approval for labeling changes to the UroVysion Bladder Cancer Kit package insert, kit and vial labeling.
P030054/S230
11/7/12
Real-Time
Epic HF, Atlas+ HF, and Promote Family of CRT-Ds St. Jude Medical
Sylmar, CA
91342
Approval for software changes to the Merlin PCS Programmer.
P040011/S002
11/2/12
180-Day
c-Kit pharmDx™ Dako North America, Inc.
Carpinteria, CA
93013
Approval for changing the company prefix to the device name (from Dako-Cytomation c-Kit pharmDx™ to c-Kit pharmDx™). The device, as modified, will be marketed under the trade name c-Kit pharmDx™.
P040016/S093
11/5/12
135-Day
VeriFLEX(Liberte) Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Approval for use of an alternate cleaning procedure.
P040021/S020
11/1/12
Real-Time
SJM Epic Valve
SJM Biocor Valve
St. Jude Medical
St. Paul, MN
55117
Approval to update the Instructions for Use (IFU), St. Jude Medical (SJM) internet, and any other applicable device labeling to include the new magnetic resonance imaging (MRI) testing information to enhance the safe use of the device when undergoing MRI.
P040043/S047
11/7/12
135-Day
GORE TAG THORACIC Endoprosthesis W.L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Approval for use of an alternate PTFE resin.
P050006/S029
11/26/12
135-Day
GORE HELEX Septal Occluder W. L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Approval for use of new testing equipment.
P050037/S023
11/6/12
135-Day
Radiesse Injectable Implant Merz Aesthetics, Inc.
Franksville, WI
53126
Approval for addition of new clean suites to existing clean room facility.
P050037/S032
11/8/12
135-Day
Radiesse Injectable Implant Merz Aesthetics, Inc.
Franksville, WI
53126
Approval for a change to syringe assembly.
P050048/S007
11/13/12
135-Day
MONOLISA™ Anti-HBs EIA and MONOLISA™ Anti-HBs Calibrator Kit Bio-Rad Laboratories, Inc.
Redmond, WA
98052
Approval for the modification of the quality control testing specification for the 400 mIU/mL Calibrator in the device.
P050052/S026
11/6/12
135-Day
Radiesse Injectable Implant Merz Aesthetics, Inc.
Franksville, WI
53126
Approval for addition of new clean suites to existing clean room facility.
P050052/S035
11/8/12
135-Day
Radiesse Injectable Implant Merz Aesthetics, Inc.
Franksville, WI
53126
Approval for a change to syringe assembly.
P060005/S008
11/8/12
135-Day
IMMULITE FPSA Assay Siemens Medical Solutions Diagnostics
East Walpole, MA
02032
Approval for eliminating the test redundancy by using only the BioRad Lyphocheck Immunoassay Plus controls in in-process component testing, post-fill testing and final kit combination testing for the assessment of IMMULITE AFP, Free PSA, and PSA/3 rd Generation PSA assay performance.
P060006/S031
11/5/12
135-Day
Express SD Monorail Premounted Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Approval for use of an alternate cleaning procedure.
P060008/S093
11/5/12
135-Day
TAXUS Liberte Paciltaxel-eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Approval for use of an alternate cleaning procedure.
P060019/S023
11/29/12
135-Day
Safire BLU and Therapy Cool Path Bi-Directional Ablation Catheters St. Jude Medical
Irvine, CA
92614
Approval for an alternate supplier of the catheter shaft subassembly.
P060023/S003
11/30/12
135-Day
Bryan Cervical Disc Medtronic Sofamor Danek
Memphis, TN
38132
Approval for a revision to the bioburden enumeration test frequency for ethylene oxide.
P070016/S005
11/5/12
135-Day
Zenith TX2 TAA Endovascular Graft Cook Incorporated
Bloomington, IN
47402
Approval for in-house manufacture of stent graft material.
P070026/S008
11/21/12
Real-Time
DePuy Ceramax Ceramic Total Hip System DePuy Orthopaedics, Incorporated
Warsaw, IN
46581
Approval for addition of Summit Porocoat Stems as a compatible component to existing 28 mm ceramic head.
P070026/S009
11/21/12
Real-Time
DePuy Ceramax Ceramic Total Hip System DePuy Orthopaedics, Incorporated
Warsaw, IN
46581
Approval for addition of Pinnacle 300, Multi-hole II and Sector II acetabular cup components.
P080011/S018
11/1/12
180-Day
Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses CooperVision, Incorporated
Pleasanton, CA
94588
Approval for a manufacturing site located at CooperVision Caribbean Corporation in Juana Diaz, Puerto Rico.
P080030/S001
11/15/12
135-Day
Glaukos Corporation iStent Trabecular Micro-Bypass Stent System Glaukos Corporation
Laguna Hills, CA
92653
Approval of the shelf-life extension for two lots of Duraflo coating material used in the device.
P080030/S002
11/8/12
135-Day
Glaukos Corporation iStent Trabecular Micro-Bypass Stent System Glaukos Corporation
Laguna Hills, CA
92653
Modifications to the design of the outer blister tray used for device packaging.
P080032/S010
11/9/12
Special
Alair Bronchial Thermoplasty System Boston Scientific Corporation
Sunnyvale, CA
94089
Approval for labeling changes to the Alair Catheter Model ATS 2-5 Directions For Use (DFU), Alair Radiofrequency (RF) Controller Model ATS 200 Operator's Manual, and Alair Bronchial Thermoplasty System Patient Brochure.
P090003/S014
11/5/12
135-Day
Express LD Monorail Iliac Premounted Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Approval for use of an alternate cleaning procedure.
P090018/S011
11/13/12
135-Day
Esteem Envoy Medical Corporation
Saint Paul, MN
55110
Approval for the EO Sterilization load configuration change for the Esteem product family.
P090026/S001
11/19/12
Special
Access Hybritech Free p2PSA reagents on the Access Immunoassay Systems Beckman Coulter, Inc.
Chaska, MN
55318
Approval for the addition of information to the Manufacturing procedures of the instrument (specifically, the instructions for application of the adhesive to the mixer pulley assembly and the implementation of a verification test to ensure the mixer pulley assemblies pass the torque specification.)
P100020/S005
11/19/12
Real-Time
cobas® HPV Test Roche Molecular Systems, Inc.
Pleasanton, CA
94558
Approval for changes to the CPU component of the cobas® z480 Analyzer.
P100024/S003
11/27/12
Real-Time
HER2 CISH pharmDx™ Kit Dako Denmark A/S
Glostrup, Denmark
DK-2600
Approval for a change in the mounting medium reagent supplied in the kit.
P100025/S003
11/6/12
Special
BreathTek® UBT for H. pylori Kit Otsuka Product Development & Commercialization, Inc.
Rockville, MD
20850
Approval for a labeling change to enhance the safe use of the device.
P100027/S003
11/14/12
Real-Time
INFORM HER-2 DUAL ISH DNA Probe Cocktail Ventana Medical Systems, Inc.
Tucson, AZ
85755
Approval for implementing a change to the Ventana regent dispenser seal for the Benchmark automated staining instruments.
P100027/S004
11/21/12
Real-Time
INFORM HER-2 Dual ISH DNA Probe Cocktail Ventana Medical Systems, Inc.
Tucson, AZ
85755
Approval for the change of the two liter (2L) bottles for each of the aqueous-based reagents from fluorinated to non-fluorinated bottles.
P100029/S008
11/1/12
Real-Time
Trifecta Heart Valve St. Jude Medical
St. Paul, MN
55117
Approval to update the Instructions for Use (IFU), St. Jude Medical (SJM) internet, and any other applicable device labeling to include the new magnetic resonance imaging (MRI) testing information to enhance the safe use of the device when undergoing MRI.
P100041/S011
11/6/12
180-Day
Edwards Sapien Transcatheter Heart Valve Edwards Lifesciences, LLC
Irvine, CA
92614
Approval of the post-approval study protocol.
P100044/S003
11/9/12
Real-Time
Propel™ Mini Sinus Implant Intersect ENT
Palo Alto, CA
94303
Approval for modifications to the stent crimper and delivery system accessory components of the device.
P110016/S005
11/29/12
135-Day
Safire BLU Duo Therapy Ablation Catheters St. Jude Medical
Irvine, CA
92614
Approval for an alternate supplier of the catheter shaft subassembly.
P110019/S031
11/20/12
180-Day
XIENCE PRIME® Everolimus Eluting Coronary Stent Systems (EECSS) Abbott Vascular, Inc.
Temecula, CA
92591
Approval to change the manufacturing and testing of the Active Pharmaceutical Ingredient (API) used in the manufacture of the device.
P110020/S004
11/19/12
Real-Time
cobas® 4800 BRAF V600 Mutation Test Roche Molecular Systems, Inc.
Pleasanton, CA
94558
Approval for changes to the CPU component of the cobas® z480 Analyzer.
P110043/S003
11/16/12
180-Day
Omnilink Elite Vascular Balloon-Expandable Stent System Abbott Vascular
Santa Clara, CA
94054
Approval for an e-beam sterilization site located at Synergy Health Ireland in Offaly, Ireland.

30-Day Notices (135 Day Supplement was not required)

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P830037/S054
11/8/12
FreshLook (phemfilcon A) Toric Soft Contact Lenses CIBA Vision Corporation
Duluth, GA
30097
Change to the production of casting cups.
P830060/S073
11/9/12
Ventak AICD System Boston Scientific Corporation
St. Paul, MN
55112
Software upgrade to the existing sterilizer system, a change in the existing sterilization process and addition of a new sterilization chamber.
P830061/S081
11/19/12
Capsure Sense Lead, Capsure Sense Unipolar Lead, Capsure Sense Bipolar Lead, Vitatron Crystalline Leads Medtronic, Inc.
Mounds View, MN
55112
Addition of an alternative testing system for electrode components.
P840001/S229
11/2/12
Spinal Cord Stimulation, Implantable Neurostimulators, Itrel 4 Medtronic Neuromodulation
Minneapolis, MN
55432
Change in the receiving inspection method used on the coated cathode current collector.
P840068/S051
11/9/12
Delta and Vista PGs Boston Scientific Corporation
St. Paul, MN
55112
Software upgrade to the existing sterilizer system, a change in the existing sterilization process and addition of a new sterilization chamber.
P850079/S058
11/8/12
Methafilcon A Soft Extended Wear Contact Lenses CooperVision, Inc.
Pleasanton, CA
94588
Change in the manufacturing remake process.
P850079/S059
11/8/12
Methafilcon A Soft (Hydrophilic) Extended Wear Contact Lenses CooperVision, Inc.
Pleasanton, CA
94588
Decrease in hydration time on Automated Wet Line (AWL) systems.
P850079/S060
11/20/12
Methafilcon A Soft (Hydrophilic) Extended Wear Contact Lenses CooperVision, Inc.
Pleasanton, CA
94588
Eliminate secondary repeat testing.
P850079/S061
11/20/12
Methafilcon A Soft (Hydrophilic) Extended Wear Contact Lenses CooperVision, Inc.
Pleasanton, CA
94588
Use of fully automated manufacturing equipment in the production of methafilcon A contact lenses.
P860004/S176
11/2/12
Drug Delivery Infusion Pumps SynchroMed Family, SynchroMed II Medtronic Neuromodulation
Minneapolis, MN
55432
Change in the receiving inspection method used on the coated cathode current collector.
P860057/S093
11/13/12
Carpentier-Edwards Perimount Pericardial Bioprosthesis Edwards Lifesciences, LLC
Irvine, CA
92614
Upgrades to the tissue treatment units.
P860057/S094
11/20/12
Carpentier-Edwards Perimount Pericardial Aortic Bioprosthesis;
Carpentier-Edwards Perimount Theon Pericardial Aortic Bioprosthesis with ThermaFix
tissue process;
Carpentier-Edwards Perimount RSR Pericardial Aortic Bioprosthesis;
Carpentier-Edwards Perimount Theon RSR Pericardial Aortic Bioprosthesis with ThermaFix tissue process;
Carpentier-Edwards Perimount Magna Pericardial Aortic Bioprosthesis;
Carpentier-
Edwards Perimount Magna Pericardial Aortic Bioprosthesis with ThermaFix
tissue process;
Carpentier-Edwards Perimount Magna Ease Pericardial Aortic Bioprosthesis with ThermaFix tissue process;
Carpentier-Edwards Perimount Plus Pericardial Mitral Bioprosthesis;
Carpentier-Edwards Perimount Theon Pericardial Mitral Bioprosthesis with ThermaFix
tissue process;
Carpentier-Edwards Perimount Magna Mitral Pericardial Bioprosthesis;
Carpentier-Edwards Perimount Magna Mitral Pericardial Bioprosthesis with ThermaFix
tissue process;
Carpentier-Edwards Perimount Magna Mitral Ease Pericardial Bioprosthesis;
Carpentier-Edwards Perimount Magna Mitral Ease Pericardial Bioprosthesis with ThermaFix tissue process;
Carpentier-Edwards Perimount Magna Mitral Ease Pericardial Bioprosthesis with ThermaFix tissue process;
Carpentier-Edwards Perimount Magna Mitral Ease Pericardial Bioprosthesis; and Carpentier-Edwards Perimount Magna Mitral Ease Pericardial Bioprosthesis with ThermaFix tissue process
Edwards Lifesciences, LLC
Irvine, CA
92614
Addition of several ovens for terminal liquid sterilization.
P860057/S095
11/26/12
Carpentier-Edwards PERIMOUNT Pericardial Bioprosthesis Edward Lifesciences, LLC
Irvine, CA
92614
Changes to clean rooms #1, 2 and 3 in the Changi, Singapore facility.
P870072/S051
11/29/12
Thoratec Ventricular Assist Devices Thoratec Corporation
Pleasanton, CA
94588
Addition of automated equipment for the annealing process of the device.
P890003/S264
11/16/12
Prodigy IPG Medtronic, Inc.
Mounds View, MN
55112
Implementation of a new cleaning process and a curing oven.
P890061/S021
11/9/12
Ventak P AICD System Boston Scientific Corporation
St. Paul, MN
55112
Software upgrade to the existing sterilizer system, a change in the existing sterilization process and addition of a new sterilization chamber.
P910073/S108
11/5/12
Endotak Lead System Boston Scientific Corporation
St. Paul, MN
55112
Modification of the lead test software.
P910073/S109
11/9/12
Endotak ICD Leads Boston Scientific Corporation
St. Paul, MN
55112
Software upgrade to the existing sterilizer system, a change in the existing sterilization process and addition of a new sterilization chamber.
P910073/S110
11/7/12
Reliance/S/G/SG IS-1 (Passive) Defibrillation Leads Boston Scientific CRM
St. Paul, MN
55112
Updates to test methods for steroid eluting leads.
P910073/S111
11/14/12
RELIANCE IS-4 Defibrillator Lead Boston Scientific Corporation
St. Paul, MN
55112
Change in the rework process to the lead terminal assembly process.
P910077/S126
11/9/12
Ventak PRx and Ventak Mini ICDs Boston Scientific Corporation
St. Paul, MN
55112
Software upgrade to the existing sterilizer system, a change in the existing sterilization process and addition of a new sterilization chamber.
P910077/S127
11/7/12
LATITUDE G2 Communicator Boston Scientific Corporation
St. Paul, MN
55112
Alternate Surface Mount Technology manufacturing line at the contract manufacturer.
P910077/S128
11/14/12
Latitude PRM Boston Scientific Corporation
St. Paul, MN
55112
Moving production of various printed circuit board assemblies to new manufacturing lines and an alternate water wash system at a supplier location.
P930035/S023
11/9/12
Ventak P2 AICD System Boston Scientific Corporation
St. Paul, MN
55112
Software upgrade to the existing sterilizer system, a change in the existing sterilization process and addition of a new sterilization chamber.
P930039/S076
11/19/12
CapSure Fix Novus Lead, Vitatron Crystalline Leads Medtronic, Inc.
Mounds View, MN
55112
Addition of an alternative testing system for electrode components.
P930039/S077
11/28/12
CapSureFix Novus Lead Medtronic, Inc.
Mounds View, MN
55112
Replacement laser welding equipment.
P940008/S030
11/9/12
RES-Q and RES-Q Micron ICDs and RES-Q ICD Leads Boston Scientific Corporation
St. Paul, MN
55112
Software upgrade to the existing sterilizer system, a change in the existing sterilization process and addition of a new sterilization chamber.
P940031/S073
11/9/12
Vigor SR/DR, Discovery and Meridian PGs Boston Scientific Corporation
St. Paul, MN
55112
Software upgrade to the existing sterilizer system, a change in the existing sterilization process and addition of a new sterilization chamber.
P950001/S024
11/9/12
Selute Pacing Lead Boston Scientific Corporation
St. Paul, MN
55112
Software upgrade to the existing sterilizer system, a change in the existing sterilization process and addition of a new sterilization chamber.
P960004/S057
11/9/12
Thinline and Fineline Pacing Leads Boston Scientific Corporation
St. Paul, MN
55112
Software upgrade to the existing sterilizer system, a change in the existing sterilization process and addition of a new sterilization chamber.
P960006/S036
11/9/12
Sweet Tip Rx, Sweet Picotip Rx and Flextend Pacing Leads Boston Scientific Corporation
St. Paul, MN
55112
Software upgrade to the existing sterilizer system, a change in the existing sterilization process and addition of a new sterilization chamber.
P960009/S159
11/2/12
DBS Implantable Neurostimulators, Activa SC Medtronic Neuromodulation
Minneapolis, MN
55432
Change in the receiving inspection method used on the coated cathode current collector.
P960040/S275
11/7/12
Prizm HE, Vitality/AVT/2, Confient, Punctua, Teligen, Energen and Incepta ICDs Boston Scientific Corporation
St. Paul, MN
55112
Additional process inspection equipment with software and fixture modifications.
P960040/S276
11/9/12
Ventak AV, Ventak Prizm DR/VR, Vitality, Confient, Livian, and Teligen
ICDs
Boston Scientific Corporation
St. Paul, MN
55112
Software upgrade to the existing sterilizer system, a change in the existing sterilization process and addition of a new sterilization chamber.
P960040/S277
11/5/12
Incepta, Energen, Punctua ICDs Boston Scientific Corporation
St. Paul, MN
55112
Change to the spot-weld process.
P960040/S278
11/5/12
Incepta, Energen, Punctua Implantable Cardioverter High Energy Defibrillators Boston Scientific Corporation
St. Paul, MN
55112
New rework process for components in the header.
P960040/S279
11/7/12
Teligen, Incepta ICD, Energen ICD and Punctua ICD Boston Scientific Corporation
St. Paul, MN
55112
Addition of plasma cleaning steps at a supplier.
P960040/S280
11/29/12
Cognis, Incepta, Energen and Punctua Cardiac Resynchronization Therapy Defibrillators Boston Scientific Corporation
St. Paul, MN
55112
Alternate supplier for a modified welding component.
D970003/S141
11/9/12
Pulsar, Pulsar Max, Insignia and Altrua PGs Boston Scientific Corporation
St. Paul, MN
55112
Software upgrade to the existing sterilizer system, a change in the existing sterilization process and addition of a new sterilization chamber.
D970003/S142
11/7/12
Insignia, Advantio, Ingenio and Altrua Pacemakers Boston Scientific Corporation
St. Paul, MN
55112
Additional process inspection equipment with software and fixture modifications.
D970003/S144
11/28/12
INGENIO, ANVANTIO Pacemakers Boston Scientific Corporation
St. Paul, MN
55112
Alternate supplier for header components.
P970004/S144
11/2/12
Sacral Nerve Stimulation, Urinary, Implantable Neurostimulators, Interstim II Medtronic Neuromodulation
Minneapolis, MN
55432
Change in the receiving inspection method used on the coated cathode current collector.
P970020/S076
11/2/12
ULTRA and ZETA RX Coronary Stent Systems Abbott Vascular
Temecula, CA
92589
Change to sampling for pyrogen testing.
P970051/S098
11/20/12
Nucleus 24 Cochlear Implant System Cochlear Americas
Centennial, CO
80111
Re-installation of a laser welder system.
P980016/S386
11/7/12
Maximo II CRT-D and Maximo II, Protecta and Protecta XT ICDs Medtronic, Inc.
Mounds View, MN
55112
Change to the burn-in testing process for tantalum capacitors.
P980016/S387
11/16/12
EnTrust, Intrinsic, Marquis DR/VR, Maximo DR/VR, Maximo II, Protecta, Protecta XT, Secura, Virtuoso, and Virtuoso II DR/VR ICDs Medtronic, Inc.
Mounds View, MN
55112
Implementation of a new cleaning process and a curing oven.
P980035/S297
11/16/12
Adapta, Adapta L, Adapta S, Sensia L, Sensia, Versa, Advisa DR,
EnRhythm, Relia, and Sigma DR IPGs
Medtronic, Inc.
Mounds View, MN
55112
Implementation of a new cleaning process and a curing oven.
P990012/S017
11/2/12
Elecsys® HBsAg Immunoassay, Elecsys® PreciControl HBsAg, and Elecsys® HBsAg Confirmatory Test Roche Diagnostics
Indianapolis, IN
46250
Change to the lyophilization process for components of the assay.
P990012/S018
11/2/12
Elecsys® HBsAg Immunoassay, Elecsys® PreciControl HBsAg, and Elecsys® HBsAg Confirmatory Test Roche Diagnostics
Indianapolis, IN
46250
Change to the functional test procedure of an assay component.
P990046/S030
11/20/12
Open Pivot Heart Valve Medtronic, Inc.
Minneapolis, MN
55432
Addition of a dual chamber coater.
P000014/S026
11/13/12
VITROS® Immunodiagnostic Products Anti-HBs Reagent Pack and Calibrator Ortho-Clinical Diagnostics, Inc.
Rochester, NY
14626
Modifications to the component parts of the Luminometer Signal Processor
Board (LSPB). The LSPB is used on the VITROS® ECi/ECiQ Immunodiagnostic System, the VITROS® 3600 Immunodiagnostic System and the VITROS® 5600 Integrated System.
P000020/S016
11/13/12
Bard Ablation System C.R. Bard, Inc.
Lowell, MA
01851
Changes to the electrical tester and barcode scanner.
P000021/S024
11/20/12
Dimension TPSA Flex Reagent Cartridge Siemens Healthcare Diagnostics, Inc.
Newark, DE
19714
New supplier of Nylon/Surlyn canister film.
P000044/S030
11/13/12
VITROS® Immunodiagnostic Products HBsAg Reagent Pack and Calibrator Ortho-Clinical Diagnostics, Inc.
Rochester, NY
14626
Modifications to the component parts of the Luminometer Signal Processor
Board (LSPB). The LSPB is used on the VITROS® ECi/ECiQ Immunodiagnostic System, the VITROS® 3600 Immunodiagnostic System and the VITROS® 5600 Integrated System.
P010012/S307
11/7/12
Contak Renewal 3/3 HE, Livian, Punctua, Cognis, Energen and Incepta CRT-Ds Boston Scientific Corporation
St. Paul, MN
55112
Additional process inspection equipment with software and fixture modifications.
P010012/S308
11/9/12
Contak CD, Livian, and Cognis CRT-Ds; and, Easytrak, Acuity, and
Spiral LV Pacing Lead
Boston Scientific Corporation
St. Paul, MN
55112
Software upgrade to the existing sterilizer system, a change in the existing sterilization process and addition of a new sterilization chamber.
P010012/S309
11/7/12
Acuity Spiral Heart Failure Leads Boston Scientific CRM
St. Paul, MN
55112
Updates to test methods for steroid eluting leads.
P010012/S310
11/5/12
Incepta, Energen, Punctua CRT-Ds Boston Scientific Corporation
St. Paul, MN
55112
Change to the spot-weld process.
P010012/S311
11/5/12
Incepta, Energen, Punctua Cardiac Resynchronization Therapy High Energy Defibrillators Boston Scientific Corporation
St. Paul, MN
55112
New rework process for components in the header.
P010012/S312
11/7/12
Cognis, Incepta CRT-D, Energen CRT-D and Punctua CRT-D Boston Scientific Corporation
St. Paul, MN
55112
Addition of plasma cleaning steps at a supplier.
P010012/S313
11/29/12
Teligen, Incepta, Energen and Punctua Implantable Cardioverter Defibrillators Boston Scientific Corporation
St. Paul, MN
55112
Alternate supplier for a modified welding component.
P010021/S023
11/13/12
VITROS® Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator Ortho-Clinical Diagnostics, Inc.
Rochester, NY
14626
Modifications to the component parts of the Luminometer Signal Processor
Board (LSPB). The LSPB is used on the VITROS® ECi/ECiQ Immunodiagnostic System, the VITROS® 3600 Immunodiagnostic System and the VITROS® 5600 Integrated System.
P010030/S038
11/20/12
LifeVest Wearable Defibrillator Zoll Lifecor Corporation
Pittsburgh, PA
15238
Modifications to a fixture and a change in the backup battery charging process during the thermal cycling.
P010031/S338
11/7/12
Consulta ICD and Maximo II, Protecta and Protecta XT
CRT-Ds
Medtronic, Inc.
Mounds View, MN
55112
Change to the burn-in testing process for tantalum capacitors.
P010031/S339
11/16/12
Concerto, Consulta, Consulta DF4, InSync III Marquis, and InSync Maximo ICDs; and, Concerto II, Maximo II, Protecta, and Protecta XT
CRT-Ds
Medtronic, Inc.
Mounds View, MN
55112
Implementation of a new cleaning process and a curing oven.
P020009/S093
11/7/12
Express Monorail and OTW Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Replace the component verification system.
P020009/S095
11/23/12
Express 2 Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Elimination of several redundant testing requirements from the balloon component manufacturing process.
P020009/S096
11/23/12
Express 2 Coronary Stent System (Monorail & OTW) Boston Scientific Corporation
Maple Grove, MN
55311
Removal of several redundant inspections at the Finished Device Inspection step.
P020027/S019
11/20/12
Dimension FPSA Flex Reagent Cartridge Siemens Healthcare Diagnostics, Inc.
Newark, DE
19714
New supplier of Nylon/Surlyn canister film.
P020047/S052
11/2/12
VISION and ML8 Coronary Stent Systems Abbott Vascular
Temecula, CA
92589
Change to sampling for pyrogen testing.
P030005/S089
11/7/12
Contak Renewal TR/TR 2, and Ivive ICDs Boston Scientific Corporation
St. Paul, MN
55112
Additional process inspection equipment with software and fixture modifications.
P030005/S090
11/9/12
Contak Renewal TR CRT-P Boston Scientific Corporation
St. Paul, MN
55112
Software upgrade to the existing sterilizer system, a change in the existing sterilization process and addition of a new sterilization chamber.
P030024/S020
11/13/12
VITROS® Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator Ortho-Clinical Diagnostics, Inc.
Rochester, NY
14626
Modifications to the component parts of the Luminometer Signal Processor
Board (LSPB). The LSPB is used on the VITROS® ECi/ECiQ Immunodiagnostic System, the VITROS® 3600 Immunodiagnostic System and the VITROS® 5600 Integrated System.
P030026/S026
11/13/12
VITROS® Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator Ortho-Clinical Diagnostics, Inc.
Rochester, NY
14626
Modifications to the component parts of the Luminometer Signal Processor
Board (LSPB). The LSPB is used on the VITROS® ECi/ECiQ Immunodiagnostic System, the VITROS® 3600 Immunodiagnostic System and the VITROS® 5600 Integrated System.
P030036/S050
11/19/12
SelectSecure 4 French Lead Medtronic, Inc.
Mounds View, MN
55112
Addition of an alternative testing system for electrode components.
P040016/S098
11/7/12
VeriFLEX (Liberté) Coronary Stent Systems Boston Scientific Corporation
Maple Grove, MN
55311
Replace the component verification system.
P040016/S100
11/23/12
VeriFlex (Liberté) Bare Metal Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Elimination of several redundant testing requirements from the balloon component manufacturing process.
P040016/S101
11/23/12
VeriFlex Coronary Stent System (Monorail & OTW) Boston Scientific Corporation
Maple Grove, MN
55311
Removal of several redundant inspections at the Finished Device Inspection step.
P040023/S025
11/20/12
Duraloc Option Ceramic Hip System DePuy Orthopaedics, Inc.
Warsaw, IN
46581
Changes to the sealing parameters for two pouch sealers used for SROM Sleeves Blister Packs.
P040024/S064
11/29/12
Restylane Injectable Gel Medicis Pharmaceutical Corporation
Scottsdale, AZ
85256
Change to a new vision system for the verification of lot number and expiration date for the assembly machine in Factory 1.
P050006/S032
11/7/12
HELEX Septal Occluder W.L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Addition of a supplier for polyvinyl alcohol (PVA).
P050019/S011
11/27/12
Carotid WALLSTENT Monorail Endoprosthesis Boston Scientific Corporation
Maple Grove, MN
55311
Addition of alternate extrusion lines for components.
P050039/S013
11/1/12
Exactech Novation Ceramic Articulation Hip System Exactech, Inc.
Gainesville, FL
32653
Addition of a new blast cabinet.
P050046/S017
11/9/12
Acuity Steerable LV Pacing Lead Boston Scientific Corporation
St. Paul, MN
55112
Software upgrade to the existing sterilizer system, a change in the existing sterilization process and addition of a new sterilization chamber.
P050048/S008
11/13/12
MONOLISA™ Anti-HBs EIA Bio-Rad Laboratories, Inc.
Redmond, WA
98052
Change to automate the filling and capping process for components in the devices.
P050051/S016
11/27/12
ARCHITECT AUSAB Abbott Laboratories, Inc.
Abbott Park, IL
60064
Change to the quality control testing used on an incoming raw material.
P060001/S018
11/7/12
Protégé GPS and Protégé RX Carotid Stent System Ev3, Inc.
Plymouth, MN
55441
Alternate microblaster.
P060006/S034
11/7/12
Express SD Renal Monorail Premounted Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Replace the component verification system.
P060006/S036
11/23/12
Express SD Renal Monorail Premounted Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Removal of several redundant inspections at the Finished Device Inspection step.
P060007/S022
11/27/12
ARCHITECT HBsAg/ Confirmatory Abbott Laboratories, Inc.
Abbott Park, IL
60064
Change to the quality control testing used on an incoming raw material.
P060031/S006
11/13/12
MONOLISA™ Anti-HBc EIA Bio-Rad Laboratories, Inc.
Redmond, WA
98052
Change to automate the filling and capping process for components in the devices.
P060033/S072
11/20/12
Endeavor Sprint Zotarolimus-Eluting Coronary Stent Systems Medtronic Vascular
Santa Rosa, CA
95403
Changes to the orientation of the sterilization cartons, location of the internal process challenge devices, and modifications to the external process challenge devices used during sterilization.
P060034/S006
11/13/12
MONOLISA™ Anti-HBc IgM EIA Bio-Rad Laboratories, Inc.
Redmond, WA
98052
Change to automate the filling and capping process for components in the devices.
P060035/S015
11/27/12
ARCHITECT CORE-M Abbott Laboratories, Inc.
Abbott Park, IL
60064
Change to the quality control testing used on an incoming raw material.
P060038/S015
11/20/12
Mitroflow Aortic Pericardial Heart Valve Sorin Group USA, Inc.
Arvada, CO
80004
Transfer of component secondary operations from supplier to in-house.
P070014/S035
11/21/12
LifeStent Vascular Stent System Bard Peripheral Vascular, Inc.
Tempe, AZ
85281
Addition of an alternate supplier to manufacture larger stent sizes.
P070015/S102
11/2/12
XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent Systems Abbott Vascular
Temecula, CA
92589
Change to sampling for pyrogen testing.
P070026/S010
11/20/12
DePuy Ceramax Ceramic Total Hip System DePuy Orthopaedics, Inc.
Warsaw, IN
46581
Changes to the sealing parameters for two pouch sealers used for SROM Sleeves Blister Packs.
P080006/S046
11/19/12
Attain Ability LV Lead, Attain Ability Plus LV Lead, Attain Ability Straight LV Lead Medtronic, Inc.
Mounds View, MN
55112
Addition of an alternative testing system for electrode components.
P080012/S009
11/6/12
Prometra Programmable Infusion Pump System Flowonix Medical, Inc.
Mt. Olive, NJ
07828
Use of an alternate solder paste during the manufacture of the device.
P080020/S003
11/1/12
Gel-One® Seikagaku Corporation
Toyko, Japan
100-0005
Replacement of an existing cold storage unit.
P080020/S004
11/30/12
Gel-One® Seikagaku Corporation
Tokyo, Japan
Increase in production capacity.
P080023/S016
11/27/12
ARCHITECT CORE Abbott Laboratories, Inc.
Abbott Park, IL
60064
Change to the quality control testing used on an incoming raw material.
P080025/S040
11/2/12
Sacral Nerve Stimulation, Bowel, Implantable Neurostimulators, InterStim II Medtronic Neuromodulation
Minneapolis, MN
55432
Change in the receiving inspection method used on the coated cathode current collector.
P080026/S004
11/1/12
RealTime HBV Assay Abbott Molecular, Inc.
Des Plaines, IL
60018
Change to the equipment utilized for identity testing of oligonucleotides.
P090002/S006
11/20/12
Pinnacle CoMplete Acetabular Hip System DePuy Orthopaedics, Inc.
Warsaw, IN
46581
Changes to the sealing parameters for two pouch sealers used for SROM Sleeves Blister Packs.
P090003/S018
11/9/12
Express LD Iliac Premounted Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Addition of an alternate resin compounder.
P090013/S077
11/16/12
Revo MRI IPG Medtronic, Inc.
Mounds View, MN
55112
Implementation of a new cleaning process and a curing oven.
P090013/S078
11/19/12
CapSureFix MRI Lead Medtronic, Inc.
Mounds View, MN
55112
Addition of an alternative testing system for electrode components.
P090013/S079
11/28/12
CapSureFix MRI Lead Medtronic, Inc.
Mounds View, MN
55112
Replacement laser welding equipment.
P090028/S004
11/13/12
VITROS® Immunodiag-nostic Products HBeAg Reagent Pack and Calibrator Ortho-Clinical Diagnostics, Inc.
Rochester, NY
14626
Modifications to the component parts of the Luminometer Signal Processor
Board (LSPB). The LSPB is used on the VITROS® ECi/ECiQ Immunodiagnostic System, the VITROS® 3600 Immunodiagnostic System and the VITROS® 5600 Integrated System.
P090028/S005
11/26/12
VITROS® Immunodiag-nostic Products Anti-HBeAg Reagent Pack and Calibrator Ortho-Clinical Diagnostics, Inc.
Rochester, NY
14626
Addition of a supplier for negative human plasma.
P100001/S003
11/13/12
VITROS® Immuno-diagnostic Products Anti-HBe Reagent Pack and Calibrator Ortho-Clinical Diagnostics, Inc.
Rochester, NY
14626
Modifications to the component parts of the Luminometer Signal Processor
Board (LSPB). The LSPB is used on the VITROS® ECi/ECiQ Immunodiagnostic System, the VITROS® 3600 Immunodiagnostic System and the VITROS® 5600 Integrated System.
P100001/S004
11/19/12
VITROS® Immuno-diagnostic Products Anti-HBe Reagent Pack and Calibrator Ortho-Clinical Diagnostics, Inc.
Rochester, NY
14626
Addition of a supplier for negative human plasma.
P100010/S020
11/7/12
Arctic Front & Arctic Front Advance Cardiac CryoAblation Catheters Medtronic CryoCath LP
Quebec, Canada
H9R 5Z8
Use of an automatic pull wire crimper.
P100010/S021
11/20/12
Arctic Front Advance Cardiac CryoAblation Catheters Medtronic, Inc.
Mounds View, MN
55112
Change to a semi-automated sanding method at a component supplier.
P100017/S003
11/1/12
RealTime HCV Assay Abbott Molecular, Inc.
Des Plaines, IL
60018
Change to the equipment utilized for identity testing of oligonucleotides.
P100020/S007
11/6/12
cobas® HPV Test Roche Molecular Systems, Inc
Pleasanton, CA
94588
Change of resin for closures, and an addition of new filling and capping equipment.
P100021/S022
11/20/12
Endurant Stent Graft System Medtronic Vascular
Santa Rosa, CA
95403
Reduction to the incoming inspection for a component assembly.
P100023/S056
11/5/12
ION Paclitaxel-Eluting Platinum Chromium Coronary Boston Scientific Corporation
Maple Grove, MN
55311
Manufacturing software changes pertaining to the catheters.
P100023/S057
11/20/12
ION Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Changes to proximal balloon bond manufacturing software.
P100023/S058
11/23/12
ION (Taxus Element) Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Elimination of several redundant testing requirements from the balloon component manufacturing process.
P100023/S059
11/23/12
ION (Taxus Element) Paclitaxel-Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Addition of a second injection molding line for manifold-hypotube assemblies.
P100023/S060
11/29/12
ION (Taxus Element) Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Modification of the distal heat shrink alignment software.
P100023/S061
11/23/12
ION (Taxus Element) Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Updates to the visual standard inspection criteria for gouges.
P100023/S062
11/23/12
ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Software upgrade to the Visicon Inspection System.
P100041/S015
11/13/12
Carpentier-Edwards P erimount, Edwards SAPIEN
Transcatheter Heart Valve
Edwards Lifesciences, LLC
Irvine, CA
92614
Upgrades to the tissue treatment units.
P110003/S002
11/13/12
LeGoo Endovascular Occlusion Gel Pluromed, Inc.
Woburn, MA
01801
Changes to the packaging configurations of the device.
P110003/S003
11/13/12
LeGoo Endovascular Occlusion Gel Pluromed, Inc.
Woburn, MA
01801
Changes to the packaging configurations by reducing the number of Tyvek pouched cannulae per sales carton.
P110010/S031
11/5/12
Promus Element Plus Everolimus-Eluting Platinum Boston Scientific Corporation
Maple Grove, MN
55311
Manufacturing software changes pertaining to the catheters.
P110010/S032
11/20/12
PROMUS Element Plus Everolimus-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Changes to proximal balloon bond manufacturing software.
P110010/S033
11/23/12
PROMUS Element Plus Everolimus-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Addition of a second injection molding line for manifold-hypotube assemblies.
P110010/S034
11/29/12
PROMUS Element Plus Everolimus-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Modification of the distal heat shrink alignment software.
P110010/S036
11/23/12
PROMUS Element Plus Everolimus-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Updates to the visual standard inspection criteria for gouges.
P110010/S037
11/23/12
PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Software upgrade to the Visicon Inspection System.
P110019/S035
11/2/12
XIENCE PRIME and XIENCE PRIME LL Everlimus Eluting Coronary Stent Systems Abbott Vascular
Temecula, CA
92589
Change to sampling for pyrogen testing.
P110023/S004
11/7/12
Everflex Self-Expanding Peripheral Stent System Ev3, Inc.
Plymouth, MN
55441
Alternate microblaster.
P110028/S005
11/14/12
Absolute Pro Vascular Self-Expanding Stent System Abbott Vascular, Inc.
Temecula, CA
92591
Modify the stent subassembly expansion process.
P110029/S006
11/19/12
ARCHITECT HBsAg Qualitative and ARCHITECT HBsAg Qualitative Confirmatory Abbott Laboratories
Abbott Park, IL
60064
Change to a quality control test method for purified antibodies used in the manufacture of the ARCHITECT HBsAg Qualitative and ARCHITECT HBsAg Qualitative
Confirmatory assays.
P110029/S007
11/27/12
ARCHITECT HBsAg Qualitative/ Confirmatory Abbott Laboratories, Inc.
Abbott Park, IL
60064
Change to the quality control testing used on an incoming raw material.
P110035/S004
11/7/12
Epic Vascular Self- Expanding Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Replace the component verification system.

Summary of PMA Originals & Supplements Approved
Originals: 4
Supplements: 92

Summary of PMA Originals Under Review
Total Under Review: 49
Total Active: 18
Total On Hold: 31

Summary of PMA Supplements Under Review
Total Under Review: 640
Total Active: 480
Total On Hold: 160

Summary of All PMA Submissions Received
Originals: 3
Supplements: 82

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 92
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 140
FDA Time: 98.7 Days MFR Time: 41.3 Days

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