Advertisement
News
Advertisement

PMA Final Decisions for August 2013

Tue, 12/03/2013 - 12:00am
U.S. Food & Drug Administration

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 APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P110002
8/7/13
Mobi-C® Cervical Disc Prosthesis LDR Spine USA, Inc.
Austin, TX
78750
Approval for the Mobi-C® Cervical Disc Prosthesis. This device is indicated in skeletally mature patients for reconstruction of the disc at one level from C3-C7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain or myelopathy due to a single-level abnormality localized to the level of the disc space and at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height compared to adjacent levels. The Mobi-C® Cervical Disc Prosthesis is implanted using an anterior approach. Patients should have failed at least 6 weeks of conservative treatment or demonstrated progressive signs or symptoms despite nonoperative treatment prior to implantation of the Mobi-C® Cervical Disc Prosthesis.
P110009
8/23/13
Mobi-C® Cervical Disc Prosthesis LDR Spine USA, Inc.
Austin, TX
78750
Approval for the Mobi-C® Cervical Disc Prosthesis. This device is indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following discectomy at two contiguous levels for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to abnormality localized to the level of the disc space and at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height compared to adjacent levels. The Mobi-C® Cervical Disc Prosthesis is implanted using an anterior approach. Patients should have failed at least 6 weeks of conservative treatment or demonstrated progressive signs or symptoms despite nonoperative treatment prior to implantation of the Mobic® Cervical Disc Prosthesis.
P120004
8/22/13
Parascript® AccuDetect® 6.1.0 Parascript, LLC
Longmont, CO
80503
Approval for the Parascript® AccuDetect® 6.1.0. This device is indicated for use in screening mammography to identify areas suspicious for breast cancer for radiologist review after completing an initial read.
P120009
8/16/13
Nit-Occlud® PDA PFM Medical Ag
Carlsbad, CA
92008
Approval for the Nit-Occlud® PDA. This device is a permanently implanted prosthesis indicated for percutaneous, transcatheter closure of small to moderate size patent ductus arteriosus with a minimum angiographic diameter less than 4 mm.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
N970012/S096
8/14/13
Special
AMS 700 ™ Inflatable Penile Prosthesis (IPP) American Medical Systems, Inc.
Minnetonka, MN 55343
Approval for modifications of the Operating Room Manual by additional emphasis, instructions, and information for tube inflation/deflation issues in the Troubleshooting, Surgical, and Post-Operative Procedure sub-sections.
P810002/S084
8/19/13
135-Day
St. Jude Medical Mechanical Heart Valve St. Jude Medical
St. Paul, MN
55117
Approval for a change to the inspection sampling plan for final leaflet ear thickness dimensions.
P830055/S132
8/6/13
135-Day
LCS® Total Knee System DePuy Orthopaedics, Inc.
Warsaw, IN
46581
Approval for changes to the process parameters for an existing package sealer and addition of an alternate package sealer.
P830055/S136
8/28/13
Special
LCS® Total Knee System DePuy Orthopaedics, Inc.
Warsaw, IN
46581
Approval for the addition of inspections to check the profile of the distal condyles as well as the medial-lateral (M/L) width and true position of the Sigma CR150 size 5 & 6 femoral components during the manufacturing process. The Sigma CR150 femoral components were previously approved as compatible components to the primary Curved RP bearing inserts and MBT Tibial Trays.
P830060/S075
8/7/13
Real-Time
VENTAK ICD Family Boston Scientific
St Paul, MN
55112
Approval for Lead Stabilizer Kit 6503 and Lead Cap Kit 6504, which are accessory kits intended to be used with the Boston Scientific Corporation (BSC) lead products approved in the devices.
P850048/S034
8/20/13
Special
Access Hybritech PSA Reagents on the Access Immunoassay Systems Beckman Coulter, Inc.
Chaska, MN
55318
Approval for updating the labeling of UniCel Dx1 Instructions for Use, Operator's Guide, Reference Manual and onboard system Help. Requested changes to the labeling include changing current caution statements to warning statements (to enhance the safety of the operator, and removing redundant caution statements), adding new caution statements (notes for procedure clarification), adding new warning statements, changing warning to caution and relocating existing warning/caution statements in order to enhance the safety in the use of the reagents on the UniCel Dxl 800/600 Immunoassay Systems and UniCel DxC 880i/860i/680i/ 660i Synchron Access Integrated Clinical Systems.
P860003/S071
8/8/13
180-Day
THERAKOS® UVAR® XTS® and CELLEX® Photopheresis Systems THERAKOS, Inc.
Bridgewater, NJ 08807
Approval for changes in two materials used in molding components of the UVAR® XTS® and CELLEX® Procedural Kits.
P860003/S074
8/28/13
Real-Time
THERAKOS® CELLEX® Photopheresis System THERAKOS, Inc.
Bridgewater, NJ 08807
Approval for a change in the adhesive used for the lidstock of the CELLEX™ Procedural Kit packaging.
P910073/S117
8/7/13
Real-Time
ENDOTAK Lead Family Boston Scientific
St Paul, MN
55112
Approval for Lead Stabilizer Kit 6503 and Lead Cap Kit 6504, which are accessory kits intended to be used with the Boston Scientific Corporation (BSC) lead products approved in the devices.
P910077/S133
8/7/13
Real-Time
VENTAK PRx MINI AICD Families Boston Scientific
St Paul, MN
55112
Approval for Lead Stabilizer Kit 6503 and Lead Cap Kit 6504, which are accessory kits intended to be used with the Boston Scientific Corporation (BSC) lead products approved in the devices.
P950018/S011
8/14/13
180-Day
Perfluoron™ Alcon Research Ltd.
Fort Worth, TX 76134
Approval for a modified stability protocol, a change in the packaging to an alternate aluminum seal with a flip-off cap, and the addition of a pre-processing modification to siliconize the stoppers used in the filling, stopping, and sealing of  Perfluoron™.
P960004/S061
8/7/13
Real-Time
THINLINE/
FINELINE Lead Family
Boston Scientific
St Paul, MN
55112
Approval for Lead Stabilizer Kit 6503 and Lead Cap Kit 6504, which are accessory kits intended to be used with the Boston Scientific Corporation (BSC) lead products approved in the devices.
P960006/S039
8/7/13
Real-Time
Sweet Tip Rx/FLEXTEND Lead Family Boston Scientific
St Paul, MN
55112
Approval for Lead Stabilizer Kit 6503 and Lead Cap Kit 6504, which are accessory kits intended to be used with the Boston Scientific Corporation (BSC) lead products approved in the devices.
P960016/S041
8/22/13
135-Day
Livewire TCTM Cardiac Ablation System and Safire™ Ablation Catheters St. Jude Medical
Minnetonka, MN 55345
Approval for changes to 1) update the manufacturing procedure to allow for the use of a motorized stylet feeder to push the stylet through the catheter lumen for electrode stringing; and 2) add an additional stringing stylet option to the manufacturing procedure.
P960043/S082
8/29/13
Real-Time
Prostar XL® Percutaneous Vascular Surgical System Abbott Vascular
Santa Clara, CA 95054
Approval for a change to the backdown detent (BDD) force specification for the Prostar XL® PVS System.
P960058/S099
8/19/13
180-Day
HiResolution Bionic Ear System Advanced Bionics, LLC
Sylmar, CA
91342
Approval to change to the Li-Ion rechargeable battery pack used with the Platinum Sound Processor (PSP) and the S-Series sound processor.
P960058/S102
8/19/13
180-Day
HiResolution Bionic Ear System
Naida CI Q70 Sound Processor
Advanced Bionics, LLC
Sylmar, CA
91342
Approval for the Naida CI Q70 Sound Processor, a smaller Behind the Ear (BTE) sound processor that has wireless connectivity. The supplement also includes a complementary set of accessories, a new clinician’s programming interface, and a new version of the SoundWave fitting software.
P970038/S023
8/20/13
Special
Access Hybritech Free PSA Reagents on the Access Immunoassay Systems Beckman Coulter, Inc.
Chaska, MN
55318
Approval for updating the labeling of UniCel Dx1 Instructions for Use, Operator's Guide, Reference Manual and onboard system Help. Requested changes to the labeling include changing current caution statements to warning statements (to enhance the safety of the operator, and removing redundant caution statements), adding new caution statements (notes for procedure clarification), adding new warning statements, changing warning to caution and relocating existing warning/caution statements in order to enhance the safety in the use of the reagents on the UniCel Dxl 800/600 Immunoassay Systems and UniCel DxC 880i/860i/680i/ 660i Synchron Access Integrated Clinical Systems.
P970051/S096
8/4/13
180-Day
Nucleus 6 Cochlear Implant System:
External sound processors, User remote assistants, Intraoperative remote assistant, and Programming Software
Cochlear Americas
Centennial, CO 80111
Approval for the Nucleus 6 Cochlear Implant System, a new suite of external accessories and programming software to be used with the Nucleus 24 Cochlear Implant, including external sound processors (CP910 and CP920), user remote assistants (CR210 and CR230), intraoperative remote assistant (CR220), and programming software (Custom Sound Suite 4 comprised of Custom Sound 4 and Custom Sound EP 4).
P980003/S038
8/28/13
Real-Time
Chilli® Cool Ablation Catheter Boston Scientific Corporation
San Jose, CA
95134
Approval for a material change to an already known material for your solder and flux.
P980022/S130
8/26/13
135-Day
Paradigm REAL-Time Insulin Pumps,
Paradigm REAL-Time Revel Insulin Pumps
Medtronic MiniMed
Northridge, CA
91325
Approval for incorporation of a new 300-ton press for molding case insert assembly and incorporation of a new ultrasonic welder for the retainer ring.
P980022/S135
8/23/13
Special
Paradigm® REAL-Time System
Paradigm® REAL-Time Revel System
Medtronic MiniMed
Northridge, CA 91325
Approval of labeling changes to the User Guide and to the two package inserts (errata sheets) for the Paradigm REAL-Time Insulin Pumps (models MMT-522, MMT-522K, MMT-722, and MMT-722K), and for the Paradigm REAL-Time Revel Insulin Pumps (models MMT-523, MMT-523K, MMT-723, and MMT-723K). The Paradigm REAL-Time Insulin Pumps are components of the Paradigm REAL-Time System and the Paradigm REAL-Time Revel Insulin Pumps are components of the Paradigm REAL-Time Revel Systems.
P980040/S041
8/21/13
180-Day
TECNIS® iTec Preloaded Delivery System Abbott Medical Optics Inc.
Santa Ana, CA 92705
Approval for a change in the packaging configuration/ delivery system for the TECNIS® 1-Piece Intraocular Lens (IOL), Model ZCB00. The new packaging configuration will function as both the primary packaging for the lens and as a sterile, disposable insertion system for delivering the lens into the eye. The TECNIS® 1-Piece IOL (Model ZCB00) in the new packaging configuration/ delivery system is designated the TECNIS iTec Preloaded Delivery System, Model PCB00, and is indicated for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.
P980041/S024
8/20/13
Special
Access AFP Reagents on the Access Immunoassay Systems Beckman Coulter, Inc.
Chaska, MN
55318
Approval for updating the labeling of UniCel Dx1 Instructions for Use, Operator's Guide, Reference Manual and onboard system Help. Requested changes to the labeling include changing current caution statements to warning statements (to enhance the safety of the operator, and removing redundant caution statements), adding new caution statements (notes for procedure clarification), adding new warning statements, changing warning to caution and relocating existing warning/caution statements in order to enhance the safety in the use of the reagents on the UniCel Dxl 800/600 Immunoassay Systems and UniCel DxC 880i/860i/680i/ 660i Synchron Access Integrated Clinical Systems.
P000008/S027
8/29/13
180-Day
LAP-BAND® Adjustable Gastric Band Allergan, Inc.
71 South Los Cameros Road
Goleta, CA
93117
Approval for changes to the packaging, sealing parameters and sterilization load size for the device.
P000040/S029
8/14/13
180-Day
GeneSys HTA System Boston Scientific Corporation
Marlborough, MA 01752
Approval for updated labeling to reflect the results of the GeneSys HTA System post-approval study protocol.
P000054/S034
8/1/13
180-Day
INFUSE Bone Graft Medtronic Spinal and Biologics
Memphis, TN 38132
Approval for a new neutralizing antibody assay.
P000058/S049
8/1/13
180-Day
INFUSE Bone Graft/LT-Cage Lumbar Tapered Fusion Device Medtronic Spinal and Biologics
Memphis, TN 38132
Approval for a new neutralizing antibody assay.
P010014/S045
8/21/13
Special
Oxford® Partial Knee System Biomet Manufacturing Corporation
Warsaw, IN
46581
Approval to update the inspection criteria used for the Oxford® Partial Knee femoral, tibial, and mobile bearing components manufactured at the Warsaw, Indiana site.
P010032/S071
8/15/13
Real-Time
St. Jude Medical’s Neurostimulation Systems-SCS Accessory Kit St. Jude Medical
Plano, TX
75024
Approval for a new tray design for the SCS Accessory Kit used with St. Jude Medical’s Neurostimulation Systems.
P010047/S027
8/8/13
135-Day
Progel Pleural Air Leak Sealant Neomend, Inc.
Irvine, CA
92618
Approval for a modified kit orientation during e-beam sterilization.
P020004/S085
8/26/13
Real-Time
GORE® EXCLUDER® AAA Endoprosthesis W.L. Gore and Associates
Flagstaff, AZ
86001
Approval for reducing the size of the second deployment line slip knot loop and a new deployment test fixture insert.
P020012/S008
8/27/13
180-Day
Bellafill® Suneva Medical, Inc.
Santa Barbara, CA 93111
Approval for a change in the trade name of your product from Artefill® to Bellafill®.
P020024/S037
8/15/13
180-Day
Amplatzer Duct Occluder II AGA Medical Corporation
Plymouth, MN 55442
Approval for the second generation AMPLATZER Duct Occluder II (ADO II) device. The device, as modified, will be marketed under the trade name AMPLATZER Duct Occluder II and is indicated for the non-surgical closure of patent ductus arteriosius (PDA).
P020025/S036
8/7/13
180-Day
IntellaTip MiFi XP Ablation Catheter and Blazer Prime XP Catheter Boston Scientific Corporation
San Jose, CA
95134
Approval for Blazer Prime XP Catheter design modifications, material packaging, labeling changes, and addition of accessories: IntellaTip MiFi Cable, Filter Module, and Reference Cable for the IntellaTip MiFi family of catheters. The device, as modified, will be marketed under the trade name IntellaTip MiFi XP Ablation Catheter and is indicated for use with the BSC Maestro 3000 Cardiac Ablation Controller and Accessories for the treatment of sustained or recurrent type I Atrial flutter in patients age 18 or older. The BSC high power Cardiac Ablation Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
P020041/S003
8/21/13
180-Day
FemCap Barrier Contraceptive FemCap Inc.
Del Mar, CA
92014
Approval for KDL Precision Molding Corporation, a manufacturing site located in Pacoima, California
P020045/S049
8/7/13
Real-Time
Freezor Cardiac Cryoablation System Medtronic CryoCath LP
Mounds View, MN 55112
Approval to replace the obsolete Central Processing Unit (CPU) of the Cryoconsole with an equivalent board and a ferrite addition to the foot pedal connector.
P030016/S025
8/22/13
180-Day
Visian Implantable Collamer Lens for Myopia (MICL) STAAR Surgical Company
Monrovia, CA
91016
Approval for a manufacturing site located at STAAR Surgical Company in Monrovia, California.
P030017/S168
8/6/13
Real-Time
Precision Spinal Cord Stimulation System Boston Scientific Neuromodulation Corporation
Valencia, CA
91355
Approval for a change of the outer box used as secondary packaging for the Precision Spectra implanted pulse generator, and the Spectra operating room cable/extension kits.
P030022/S023
8/1/13
135-Day
Reflection Ceramic Hip System Smith & Nephew, Inc.
Memphis, TN 38116
Approval for two changes made by at a raw material supplier: 1) the forging process of the R3 Acetabular shells; and 2) the blast media used for an in process blast operation for the Synergy Femoral Stems.
P030022/S024
8/6/13
135-Day
Reflection Ceramic Hip System Smith & Nephew, Inc.
Memphis, TN 38116
Approval for a software change to analyze the STIKTITE porous coatings.
P030022/S025
8/30/13
Real-Time
Reflection Ceramic Hip System Smith & Nephew, Incorporated
Cordova, Tennessee 38016
Approval for 1) additional sizes of R3 Ceramic Liners; and 2) revision of the Reflection Ceramic Hip System labeling (Surgical Technique Manual and Surgeon Labeling) to reflect the additional components.
P030050/S015
8/15/13
135-Day
Sculptra (Injectable poly-L-lactic acid) Valeant Pharmaceuticals North America, LLC
Bridgewater, NJ 08807
Approval for requalification of the contract sterilizer of record; addition of an alternative sterilization site, and replacement of the gamma radiation source for the sterility equipment.
P040002/S042
8/26/13
Real-Time
AFX Endovascular AAA System Endologix, Inc.
Irvine, CA
92618
Approval for the addition of new guidewire subassembly provided by Acme Monaco.
P040002/S043
8/12/13
Real-Time
AFX Endovascular AAA System Endologix, Inc.
Irvine, CA
92618
Approval of new platinum/tungsten radiopaque coil markers to be added circumferentially in the proximal hem of the suprarenal and infrarenal proximal extension accessory stent grafts.
P040025/S013
8/29/13
180-Day
Olympic Cool-Cap® System Natus Medical Incorporated
Seattle, WA
98108
Approval for a software patch that allows the watchdog timer to reboot the device and initiate a power failure recovery alarm in the event of a screen freeze condition.
P040044/S047
8/19/13
180-Day
Mynx Ace Vascular Closure Device Access Closure, Inc.
Mountain View, CA 94043
Approval for modifications to the delivery system that composes the MynxGrip Vascular closure device. The device, as modified, will be marketed under the trade name Mynx Ace Vascular Closure Device ("Mynx Ace") and is indicated for use to seal femoral arterial access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F or 7F procedural sheath.
P050038/S017
8/6/13
180-Day
ARISTA AH Absorbable Hemostat Medafor, Inc.
Minneapolis, MN 55430
Approval for a manufacturing site located in  Minneapolis, Minnesota.
P050053/S024
8/1/13
180-Day
INFUSE Bone Graft Medtronic Spinal and Biologics
Memphis, TN 38132
Approval for a new neutralizing antibody assay.
P060010/S011
8/28/13
180-Day
Spanner Temporary Prostatic Stent and Accessories  SRS Medical Systems, Inc.
North Billerica, MA
01862
Approval for a manufacturing site located at ProMed Pharma LLC, in Minneapolis, Minnesota.
P070026/S012
8/6/13
135-Day
Ceramax Ceramic Total Hip System DePuy Orthopaedics, Inc.
Warsaw, IN
46581
Approval for changes to the process parameters for an existing package sealer and addition of an alternate package sealer.
P070026/S017
8/27/13
180-Day
CERAMAX® Ceramic Total Hip System Depuy, Inc.
Warsaw, IN
46581
Approval of the post-approval study protocol.
P080027/S012
8/1/13
Special
OraQuick® HCV Rapid Antibody Test OraSure Technologies, Inc.
Bethlehem, PA 18015
Approval for adding more replicates in QC testing procedures.
P090002/S009
8/6/13
135-Day
Pinnacle CoMplete Acetabular System DePuy Orthopaedics, Inc.
Warsaw, IN
46581
Approval for changes to the process parameters for an existing package sealer and addition of an alternate package sealer.
P090026/S007
8/20/13
Special
Access Hybritech p2PSA Reagents on the Access Immunoassay Systems Beckman Coulter, Inc.
Chaska, MN
55318
Approval for updating the labeling of UniCel Dx1 Instructions for Use, Operator's Guide, Reference Manual and onboard system Help. Requested changes to the labeling include changing current caution statements to warning statements (to enhance the safety of the operator, and removing redundant caution statements), adding new caution statements (notes for procedure clarification), adding new warning statements, changing warning to caution and relocating existing warning/caution statements in order to enhance the safety in the use of the reagents on the UniCel Dxl 800/600 Immunoassay Systems and UniCel DxC 880i/860i/680i/ 660i Synchron Access Integrated Clinical Systems.
P100010/S029
8/7/13
Real-Time
Arctic Front Cardiac Cryoablation System Medtronic CryoCath LP
Mounds View, MN 55112
Approval to replace the obsolete Central Processing Unit (CPU) of the Cryoconsole with an equivalent board and a ferrite addition to the foot pedal connector.
P100031/S009
8/12/13
180-Day
Elecsys® Anti-HBc Immunoassay and Elecsys® PreciControl Anti-HBc Roche Diagnostics
Indianapolis, IN 46250
Approval for the migration of claims from the FDA approved Elecsys Anti-HBc Immunoassay and Elecsys PreciControl Anti-HBc on the MODULAR ANALYTICS E170 to the cobas e 602 immunoassay analyzer. The device, as modified, will be marketed under the trade name Elecsys Anti-HBc Immunoassay and Elecsys PreciControl Anti-HBc and is indicated for: Elecsys Anti-HBc Immunoassay The Elecsys Anti-HBc immunoassay is intended for the in vitro qualitative determination of total antibodies to hepatitis B core antigen (anti-HBc) in human serum and plasma (lithium heparin, sodium citrate, K2-EDTA) in adult patients with the symptoms of hepatitis or who may be at risk for hepatitis B virus (HBV) infection. The detection of total anti-HBc is indicative of a laboratory diagnosis for HBV infection. Further HBV serological marker testing is required to define the specific disease state. The Elecsys Anti-HBc immunoassay’s performance has not been established for the monitoring of HBV disease or therapy. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the MODULAR ANALYTICS E170 and cobas e 602 immunoassay analyzers. Elecsys PreciControl Anti-HBc PreciControl Anti HBc is used for quality control of the Elecsys Anti HBc immunoassay on the MODULAR ANALYTICS E170 and cobas e 602 immunoassay analyzers.
P100034/S004
8/8/13
180-Day
NovoTTF-100A System NovoCure, Ltd.
Portsmouth, NH
03801
Approval for transferring the responsibility of performing the NovoTAL Transducer Array Mapping from Novocure’s staff to trained physicians responsible for prescribing the device.
P100044/S010
8/13/13
Special
Propel® and Propel Mini Sinus Implant Intersect ENT
Menlo Park, CA 94025
Approval for modifications to the Instructions For Use (IFU) and labels that enhance the safety in the use of the Propel and Propel Mini sinus implants.
P100047/S021
8/30/13
180-Day
HeartWare® Ventricular Assist System HeartWare, Inc.
Miami Lakes, FL 33014
Approval to modify the outer diameter and thickness of the pump’s driveline sheath tubing.
P100047/S023
8/30/13
Real-Time
HeartWare® Ventricular Assist System HeartWare, Inc.
Miami Lakes, FL 33014
Approval for the HeartWare® Waist Pack and the HeartWare® Shoulder Pack.
P110013/S011
8/22/13
135-Day
Resolute Integrity Zotarolimus-Eluting Coronary Stent System Medtronic Vascular
Santa Rosa, CA 95403
Approval for a change to the sample preparation extraction solution and diluents for the butylated hydroxytoluene (BHT) analytical quality control test.
P110016/S007
8/29/13
180-Day
Safire™ Duo/Cool Path™ Duo Ablation Catheters, VeriSense Enabled™, IBI 1500T9-CP V1.6 Cardiac Ablation Generator and VeriSense™ System St. Jude Medical
Minnetonka, MN 55345
Approval for the Safire™ Duo/Cool Path™ Duo Ablation Catheters, VeriSense Enabled™, IBI 1500T9-CP V1.6 Cardiac Ablation Generator and VeriSense™ System. This device is indicated for use with the compatible Irrigation pump and the1500T9-CP Radiofrequency (RF) Generator at a maximum of 50 watts. The catheters are intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of typical atrial flutter.
P110022/S011
8/6/13
Special
Elecsys® Anti-HBc IgM Immunoassay on the cobas e 601 Analyzer Roche Diagnostics Corporation
Indianapolis, IN 46250
Approval for a change to the specification for in-process testing of a bulk reagent.
P110025/S010
8/6/13
Special
Elecsys® Anti-HBc IgM Immunoassay on the MODULAR ANALYTICS E170 Analyzer Roche Diagnostics Corporation
Indianapolis, IN 46250
Approval for a change to the specification for in-process testing of a bulk reagent.
P110031/S010
8/6/13
Special
Elecsys® Anti-HBc IgM Immunoassay on the cobas e 411 Analyzer Roche Diagnostics Corporation
Indianapolis, IN 46250
Approval for a change to the specification for in-process testing of a bulk reagent.
P110039/S003
8/6/13
180-Day
ExAblate System InSightec
Dallas, TX
75244
Approval of the post-approval study protocol.
P110042/S009
8/28/13
180-Day
Subcutaneous Implantable Defibrillator (S-ICD®) System Cameron Health Inc.
San Clemente, CA 92673
Approval for Model 3200 Q-TECH Programmer to be used with SQ-RX® Pulse Generator (Model 1010) of the Subcutaneous Implantable Defibrillator (S-ICD®) System only.
P110042/S011
8/12/13
Real-Time
Subcutaneous Implantable Defibrillator (S-ICD®) System Cameron Health, Inc.
San Clemente, CA 92673
Approval for Software Maintenance Release SMR7.
P110042/S012
8/20/13
Real-Time
Subcutaneous Implantable Defibrillator (S-ICD®) System Cameron Health, Inc.
San Clemente, CA 92673
Approval for two alternate components used on the Low Power Hybrid Assembly for the S-ICD System.
P120005/S005
8/14/13
Real-Time
Dexcom G4 Platinum Continuous Glucose Monitoring System Dexcom, Inc.
San Diego, CA 92121
Approval for modifications to the G4 Platinum Firmware for the G4 Platinum Continuous Glucose Monitoring System to include code revisions and firmware changes to improve communications, updates to the flash memory and the USB, plus a single change to a documentation revision in the software requirements specification but no changes to the code were performed.
P120006/S004
8/27/13
180-Day
Ovation/Ovation Prime Abdominal Stent Graft System Trivascular Inc
Santa Rosa, CA 95403
Approval of the post-approval study protocol.
P120008/S002
8/27/13
180-Day
ARCHITECT AFP Assay Abbott Laboratories
Abbott Park, IL 60064
Approval for migration of ARCHITECT AFP assay to the ARCHITECT i System family member, the ARCHITECT il000SR.

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

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
N18033/S073
8/16/13
Vistakon (etafilcon A) Soft Contact Lenses Johnson & Johnson Vision Care, Incorporated
Jacksonville, FL 32256
Add an alternate supplier for a component of the primary packaging.
N970003/S154
8/22/13
VITALIO, FORMIO Families of Pacemakers Boston Scientific Corporation
St. Paul, MN
55112
Alternate sterilization cycle to reduce the evacuation dwell time during the Ethylene Oxide removal phase.
P780007/S051
8/20/13
CooperVision Polymacon Soft (Hydrophilic) Extended-Wear Contact Lenses CooperVision, Incorporated
Pleasanton, CA 94588
Addition of new equipment to measure airborne particles at the Juana Diaz, Puerto Rico facility.
P810002/S087
8/8/13
St. Jude Medical Mechanical Heart Valves St. Jude Medical
St. Paul, MN
55117
Change to the fabric supplier location.
P810006/S044
8/29/13
CollaStat Absorbable Collagen Hemostatic Sponge
CollaStat Absorbable Collagen Hemostatic Agent-Microfibrillar Form
Integra LifeSciences, Corp.
Plainsboro, NJ 08536
Increase in the sample size for Bacterial Endotoxin Testing (BET) for all Collagen products manufactured at the Plainsboro New Jersey facility and at the Anasco, Puerto Rico location.
P810006/S045
8/23/13
Collastat™, Absorable Collagen Hemostatic Sponge, Collastat™ Absorbable Collagen hemostatic Agent- Microfibrillar Form Integra LifeSciences, Corp.
Plainsboro, NJ 08536
Change to a component shipping container.
P810025/S034
8/13/13
Amvisc and Amvisc Plus Ophthalmic Viscosurgical Device Bausch & Lomb
Aliso Viejo, CA 92656
Change in the existing clean room into a formulation room.
P810031/S050
8/15/13
Healon 10-mg/mL, Healon GV 14-mg/mL and Healon5 23-mg/mL
Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD)
Abbott Medical Optics, Inc.
Santa Ana, CA 92705
Sodium hyaluronate raw material quality control testing.
P820003/S122
8/9/13
Disposable Patient Cables for the Model 5348 and Model 5388 Temporary Pacemakers Medtronic, Inc.
Mounds View, MN 55112
Packaging site and product release changes for the Model 5846 Disposable Patient Cables.
P840001/S243
8/2/13
Spinal Cord Stimulation (SCS) Neurostimulators Implantable (INS) Restore Devices Medtronic Neurostimulation
Minneapolis, MN 55432
Changes within the RestoreSmall battery burn-in and inspection process.
P840001/S244
8/1/13
SCS INS Itrel Family, SCS INS Restore Family,
SCS Sure Scan MRI INS Family
Medtronic Neuromodulation
Minneapolis, MN 55432
Change to reduce the hybrid production burn-in time for the  impacted products.
P840001/S245
8/12/13
Spinal Cord Stimulation (SCS) Implantable Neurostimulator (INS) Itrel Family (Itrel4), SCS INS Restore Family (RestorePrime, PrimeAdvanced, RestoreUltra,
RestoreAdvanced, and RestoreSensor), and SCS Sure Scan MRI INS Family
(PrimeAdvanced SureScan MRI, RestoreUltra SureScan MRI, RestoreAdvanced
SureScan MRI and RestoreSensor SureScan MRI)
Medtronic Neuromodulation
Minneapolis, MN 55432
Alternate first tier supplier of extension/connector end assemblies and electrode end assemblies.
P840001/S246
8/27/13
SCS Neurostimulators External, SCS Neurostimulators Implantable Itrel Family, SCS Neurostimulators Implantable Restore Family Medtronic Neuromodulation
Minneapolis, MN 55432
Change to include an additional incoming material acceptance test method for Underfill Epoxy.
P840062/S031
8/29/13
CollaCote™, CollaTape®, CollaPlug® Absorbable Collagen Wound Dressing for Dental Surgery Integra LifeSciences, Corp.
Plainsboro, NJ 08536
Increase in the sample size for Bacterial Endotoxin Testing (BET) for all Collagen products manufactured at the Plainsboro New Jersey facility and at the Anasco, Puerto Rico location.
P840062/S032
8/23/13
CollaCote™, CollaTape®, CollaPlug® Absorbable Collagen Wound Dressing for Dental Surgery Integra LifeSciences, Corp.
Plainsboro, NJ 08536
Change to a component shipping container.
P840064/S055
8/7/13
PROVISC, DUOVISC and DISCOVISC Ophthalmic Viscosurgical Devices Alcon Laboratories, Incorporated
Fort Worth, TX 76134
Use of a compounding isolator for sterile incorporation.
P850010/S042
8/29/13
HeliStat®, Helitene® Absorbable Collagen Hemostatic Agents Integra LifeSciences, Corp.
Plainsboro, NJ 08536
Increase in the sample size for Bacterial Endotoxin Testing (BET) for all Collagen products manufactured at the Plainsboro New Jersey facility and at the Anasco, Puerto Rico location.
P850010/S043
8/23/13
HeliStat®, Helitene® Absorbable Collagen Hemostatic Agents Integra LifeSciences, Corp.
Plainsboro, NJ 08536
Change to a component shipping container.
P860004/S192
8/1/13
Drug Delivery Infusion Pumps SynchroMed Family Medtronic Neuromodulation
Minneapolis, MN 55432
Change to reduce the hybrid production burn-in time for the  impacted products.
P860004/S193
8/5/13
SynchroMed II Implantable Infusion Pump Medtronic Neuromodulation
Minneapolis, MN 55432
Addition of an alternate supplier to manufacture a printed circuit board assembly at an alternate facility.
P860004/S194
8/27/13
Drug Delivery Infusion Pumps SynchroMed Family Medtronic Neuromodulation
Minneapolis, MN 55432
Change to include an additional incoming material acceptance test method for Underfill Epoxy.
P860057/S110
8/16/13
Carpentier-Edwards PERIMOUNT Magna Mitral Ease Pericardial
Bioprosthesis with ThermaFix tissue process
Edwards Lifesciences, LLC.
Irvine, CA
92614
Change to the resin used in a component material in the Tricentrix Holder System and Jar Assembly.
P890003/S282
8/22/13
Prodigy Implantable Pulse Generator Medtronic, Inc.
Mounds View, MN 55112
Alternate suppliers for molded silicone components.
P890023/S019
8/21/13
CooperVision Ocufilcon D Soft Extended-Wear Contact Lenses CooperVision, Incorporated
Pleasanton, CA 94588
Addition of new equipment to measure airborne particles in the Juana Diaz, Puerto Rico facility.
P890040/S007
8/6/13
Sof-Form 55 EW, Softcon EW 2 and LL-55 Soft Hydrophilic Contact Lenses Unilens Corporation, USA
Largo, Florida 33777
Direct hydration of lenses.
P890047/S041
8/7/13
PROVISC, DUOVISC and DISCOVISC Ophthalmic Viscosurgical Devices Alcon Laboratories, Incorporated
Fort Worth, TX 76134
Use of a compounding isolator for sterile incorporation.
P900033/S031
8/29/13
INTEGRA® Artificial Skin Dermal Regeneration Template Integra LifeSciences, Corp.
Plainsboro, NJ 08536
Increase in the sample size for Bacterial Endotoxin Testing (BET) for all Collagen products manufactured at the Plainsboro New Jersey facility and at the Anasco, Puerto Rico location.
P910001/S066
8/21/13
CVX-300 and CVX-300-P Excimer Laser Systems Spectranetics Corporation
Colorado Springs, CO
80921
Change in the primary vendor for the electrode plating process.
P910023/S320
8/28/13
ATLAS, ONVERT, CURRENT, ELLIPSE, EPIC, FORTIFY, FORTIFY ASSURA,  PHOTON ICD Devices St. Jude Medical
Sylmar, CA
91342
Alternate location for the parylene coating process.
P910061/S020
8/21/13
SofPort Posterior Chamber Intraocular Lens (IOL) Bausch & Lomb Incorporated
Aliso Viejo, CA  92656
Addition of an alternate packaging component supplier.
P910077/S136
8/21/13
Programmer/Recorder/Monitor (PRM), Zoom LATITUDE Programmer Boston Scientific Corporation
Saint Paul, MN 55112
Alternate supplier for the off-the-shelf flash memory chip to be used on the input/output (I/O) printed circuit assembly (PCA) of the device.
P920015/S114
8/22/13
Y Adaptor/Extender Kit, HV Splitter/ Adaptor Kit Medtronic, Inc.
Mounds View, MN 55112
Alternate suppliers for molded silicone components.
P950029/S080
8/13/13
Reply SR, Reply DR, Espirit SR, Espirit DR Pacemakers Sorin CRM USA, Inc.
Arveda, CO
80004
Addition of non-functional structures within the metal layers and the modification of the visual inspection process for integrated circuits in the implantable pulse generators.
P950032/S074
8/13/13
Apligraf Organogenesis, Inc.
Canton, MA
02021
Alternate vendor to supply processing trays for use in the manufacturing process of Apligraf.
P950037/S126
8/14/13
ECURO, EFFECTA, ESTELLA, EVIA, ENTOVIS Pacemakers BIOTRONIK, Inc.
Lake Oswego, OR 97035
Implement a new ethylene oxide sterilization cycle at a contract sterilization site.
P950029/S082
8/30/13
Reply SR, Reply DR, Esprit SR, Esprit DR Pacemakers Sorin CRM USA, lnc.
Arveda, CO
80004
Alternative laser welding equipment for the closing of  the devices.
P960009/S174
8/2/13
Deep Brain Stimulation (DBS) INS Activa Devices Medtronic Neurostimulation
Minneapolis, MN 55432
Changes within the RestoreSmall battery burn-in and inspection process.
P960009/S175
8/1/13
DBS INS Activa Family Medtronic Neuromodulation
Minneapolis, MN 55432
Change to reduce the hybrid production burn-in time for the  impacted products.
P960009/S176
8/12/13
Deep Brain Stimulation (DBS) INS Activa Family (Activa PC, Activa
SC, and Activa RC)
Medtronic Neuromodulation
Minneapolis, MN 55432
Alternate first tier supplier of extension/connector end assemblies and electrode end assemblies.
P960009/S177
8/27/13
Activa DBS Lead & Activa DBS Lead-Reduced Spacing Medtronic Neuromodulation
Minneapolis, MN 55432
Addition of a new annealing vacuum oven.
P960009/S178
8/27/13
DBS Neurostimulators External, DBS Neurostimulators Implantable Activa Family Medtronic Neuromodulation
Minneapolis, MN 55432
Change to include an additional incoming material acceptance test method for Underfill Epoxy.
P970004/S157
8/1/13
SNS Urinary INS InterStim Family Medtronic Neuromodulation
Minneapolis, MN 55432
Change to reduce the hybrid production burn-in time for the  impacted products.
P970051/S111
8/26/13
Nucleus 24 Cochlear Implant System Cochlear Americas
Centennial, Colorado
80111
Addition of a second identical brazing oven.
P980016/S427
8/14/13
Evera S VR, Evera S DR, Evera XT VR, and Evera XT DR Implantable Cardioverter Defibrillators Medtronic, Inc.
Mounds View, MN 55112
Implementation of an updated battery dimensional inspection routine.
P980016/S428
8/12/13
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR
ICD, Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD,
Virtuoso II DR/VR ICD
Medtronic, Inc.
Mounds View, MN 55112
Change for an incoming material acceptance procedure for underfill cure epoxy.
P980016/S429
8/22/13
Evera S DR ICD, Evera S VR ICD,
Evera XT DR ICD and Evera XT VR ICD
Medtronic CRDM
Mounds View, MN 55112
Implement the use of a semi-automated vision system to verify the crimp height of the capacitor feedthrough in the devices.
P980016/S430
8/22/13
Evera ICD, Intrinsic ICD, Marquis ICD, Maximo ICD Medtronic, Inc.
Mounds View, MN 55112
Alternate suppliers for molded silicone components.
P980035/S339
8/12/13
Adapta, Versa, Sensa IPG, Advisa DR IPG, Advisa DR MRI IPG,
Relia IPG
Medtronic, Inc.
Mounds View, MN 55112
Change for an incoming material acceptance procedure for underfill cure epoxy.
P980035/S340
8/22/13
Adapta, Versa, Advisa , Advisa MRI IPGs Medtronic, Inc.
Mounds View, MN 55112
Alternate suppliers for molded silicone components.
P980049/S083
8/13/13
Paradym VR, Paradym DR, Paradym RF VR, Paradym RF DR Sorin CRM USA, Inc.
Arveda, CO
80004
Addition of non-functional structures within the metal layers and the modification of the visual inspection process for integrated circuits in the implantable pulse generators.
P980053/S015
8/19/13
Durasphere Injectable Bulking Agent Carbon Medical Technologies, Inc.
Saint Paul, MN 55110
Addition of a new texture analyzer system.
P990001/S115
8/22/13
Vitatron C20 SR Implantable Pulse Generator Medtronic, Inc.
Mounds View, MN 55112
Alternate suppliers for molded silicone components.
P990046/S035
8/7/13
Open Pivot Heart Valve; Open Pivot Aortic Valved Graft Medtronic, Inc.
Minneapolis, MN 55432
Review of: 1) installation qualification (IQ) reports for 4 pieces of equipment related to an already approved site change supplement; and 2) one process qualification (PQ) report for one piece of equipment related to an already approved site change supplement. These changes apply to the Open Pivot Heart Valve and Open Pivot Aortic Valved Graft.
P990075/S024
8/20/13
Mentor SPECTRUM Breast Implants Mentor Worldwide LLC
Santa Barbara, CA 93111
Add an additional sub-supplier of the connector system that is provided as an accessory with the devices.
P990081/S021
8/22/13
PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody Ventana Medical Systems, Inc.
Tucson, AZ
85755
Add a supplier (FeF Chemicals) of a raw material (recombinant human insulin) for the BD Cell MAb Media base and to bring the formulation of this media from Becton Dickinson into in-house production at Ventana Medical Systems, Inc., in  Tucson, Arizona.
P000025/S071
8/7/13
MAESTRO Cochlear Implant System MED-EL Elektro-Medizinische Geräte GmbH
Austria
A-6020
Standardization of electrode reinforcement springs.
P000025/S073
8/15/13
COMBI 40+ Cochlear Implant System (Mi1000 MED-EL CONCERT) MED-EL Elektro-Medizinische Geräte GmbH
Austria
A-6020
Qualification of an additional welding process.
P010013/S048
8/20/13
NovaSure Impedance Controlled Endometrial Ablation System Hologic, Inc.
Marlborough, MA
01752
Change from a manual inspection process to an automated inspection process of incoming device components.
P010015/S210
8/12/13
Consulta CRT-P, Syncra CRT-P Medtronic, Inc.
Mounds View, MN 55112
Change for an incoming material acceptance procedure for underfill cure epoxy.
P010015/S211
8/22/13
Consulta CRT-P and Syncra CRT-P Medtronic, Inc.
Mounds View, MN 55112
Alternate suppliers for molded silicone components.
P010019/S035
8/28/13
Lotrafilcon Soft Contact Lenses for Extended Wear CIBA Vision Corporation
Duluth, GA
30097
Packaging line upgrade.
P010031/S388
8/14/13
Brava, Viva S, and Viva XT Cardiac Resynchronization Therapy
Defibrillators
Medtronic, Inc.
Mounds View, MN 55112
Implementation of an updated battery dimensional inspection routine.
P010031/S389
8/12/13
Brava CRT-D, Concerto II CRT-D, Consulta ICD, Maximo II CRT-D,
Protecta CRT-D, Protecta XT CRT-D, Viva S CRT-D, Viva XT CRTD
Medtronic, Inc.
Mounds View, MN 55112
Change for an incoming material acceptance procedure for underfill cure epoxy.
P010031/S390
8/22/13
Brava CRT-D, Viva S CRT-D and Viva XT CRT-D Medtronic CRDM
Mounds View, MN 55112
Implement the use of a semi-automated vision system to verify the crimp height of the capacitor feedthrough in the devices.
P010031/S391
8/22/13
Brava CRT-D, Concerto CRT-D, Consulta ICD Medtronic, Inc.
Mounds View, MN 55112
Alternate suppliers for molded silicone components.
P010047/S031
8/1/13
Progel® Pleural Air Leak Sealant Neomend Inc.
Irvine, CA
92618
Changes in the UV bonding process for the Progel® Extended Tips provided with the Progel Pleural Air Leak Sealant kit.
P020004/S086
8/5/13
GORE® EXCLUDER AAA Endoprosthesis W.L. Gore and Associates
Flagstaff, AZ
86001
New wrapper machine.
P020012/S008
8/27/13
180-Day
Bellafill® Suneva Medical, Inc.
Santa Barbara, CA 93111
Change in the trade name of your product from Artefill® to Bellafill®.
P020025/S042
8/14/13
Maestro 3000 Cardiac Ablation System Boston Scientific Corporation
San Jose, CA
95134
Acceptance of the validation of the Hi-Pot test equipment used in the in-process RF board testing.
P030005/S101
8/22/13
INTUA Family of CRT-Ps Boston Scientific Corporation
St. Paul, MN
55112
Alternate sterilization cycle to reduce the evacuation dwell time during the Ethylene Oxide removal phase.
P030009/S066
8/29/13
Integrity Over-the-Wire Coronary Stent Systems Medtronic Vascular
Santa Rosa, CA 95403
Introduce an alternative building for the manufacture of the MicroTrac OTW delivery system within the same approved manufacturing facility.
P030017/S173
8/1/13
Precision Spectra Spinal Cord Stimulator System Boston Scientific Corporation
Valencia, CA
91355
Update the test equipment system for the Printed Circuit Board Assembly for the Implantable Pulse Generator.
P030017/S175
8/16/13
Precision Spectra Spinal Cord Stimulator System Boston Scientific Corporation
Valencia, CA
91355
Modify the leak detection testing.
P030017/S176
8/21/13
Precision Spectra Spinal Cord Stimulator System Boston Scientific Corporation
Valencia, CA
91355
Add new acceptance criteria to the charging coil.
P030031/S054
8/22/13
Celsius ThermoCool, Celsius RMT ThermoCool Catheters Biosense Webster, Inc.
Diamond Bar, CA 91765
Addition of a second source supplier for the manufacturing of tip electrodes for the family of products.
P030050/S018
8/16/13
Sculptra (Injectable poly-L-lactic acid) Valeant Pharmaceuticals North America, LLC
Bridgewater, NJ 08807
The following changes: 1) Replacement of the gamma radiation source and requalification of sterilization at the Dagneux France facility; 2) Packaging modification for the raw material, including a new bag supplier and the introduction of a new bagging configuration; and 3) Replacement of the gamma radiation source and requalification at the Sablé France facility.
P030054/S252
8/28/13
ATLAS, EPIC, PROMOTE, QUADRA ASSURA, UNIFY, UNIFY
ASSURA, UNIFY QUADRA CRT-D Devices
St. Jude Medical
Sylmar, CA
91342
Alternate location for the parylene coating process.
P040005/S010
8/28/13
HER2 IQFISH pharmDx Dako Denmark A/S
Glostrup, Denmark
DK-2600
Additional probe DNA labeling option for labeling DNA pools.
P040012/S052
8/27/13
RX Acculink Carotid Stent System Abbott Vascular
Santa Clara, CA 95054
Change to the electropolish solution used in the manufacture of the stents of the devices.
P040027/S031
8/5/13
GORE® VIATORR® TIPS Endoprosthesis W.L. Gore and Associates
Flagstaff, AZ
86001
New wrapper machine.
P040036/S038
8/22/13
NaviStar-, Navistar RMT-, EZ Steer- ThermoCool Catheters Biosense Webster, Inc.
Diamond Bar, CA 91765
Addition of a second source supplier for the manufacturing of tip electrodes for the family of products.
P040037/S054
8/5/13
GORE® VIABAHN® Endoprosthesis W.L. Gore and Associates
Flagstaff, AZ
86001
New wrapper machine.
P040043/S056
8/5/13
GORE® TAG® Thoracic Endoprosthesis W.L. Gore and Associates
Flagstaff, AZ
86001
New wrapper machine.
P040045/S040
8/16/13
Vistakon (senofilcon A) Soft Contact Lenses Johnson & Johnson Vision Care, Incorporated
Jacksonville, FL 32256
Add an alternate supplier for a component of the primary packaging.
P050006/S036
8/5/13
GORE® HELEX® Septal Occluder W.L. Gore and Associates
Flagstaff, AZ
86001
New wrapper machine.
P050012/S051
8/19/13
Dexcom Seven® Plus Continuous Glucose Monitoring System Dexcom, Inc.
San Diego, CA 92121
Addition of a -20°C upright laboratory freezer to the sensor manufacturing equipment.
P050017/S008
8/22/13
Zilver Vascular Stent Cook Medical Incorporated
Bloomington, IN 47402
Change the manufacturing process of flaring the polyethylene reinforced sleeves from a manual process to an automated process.
P050018/S019
8/21/13
AngioSculpt PTCA Scoring Balloon Catheter AngioScore, Inc.
Fremont, CA
94538
Additional pouch sealers.
P050023/S068
8/14/13
IFORIA, ILESTO, LUMAX ICDs and CRT-Ds BIOTRONIK, Inc.
Lake Oswego, OR 97035
Implement a new ethylene oxide sterilization cycle at a contract sterilization site.
P050034/S010
8/9/13
Implantable Miniature Telescope (IMT) VisionCare Ophthalmic Technologies
Saratoga, California 95070
Add an assembly jig into the manufacturing process.
P050042/S025
8/30/13
ARCHITECT Anti-HCV Abbott Laboratories
Diagnostics
Abbott Park, IL 60064
Elimination of the specificity panel testing used to determine the effectiveness of a preventive action.
P060027/S051
8/13/13
Paradym CRT-D, Paradym RF CRT-D Sorin CRM USA, Inc.
Arveda, CO
80004
Addition of non-functional structures within the metal layers and the modification of the visual inspection process for integrated circuits in the implantable pulse generators.
P060030/S033
8/21/13
COBAS® AmpliPrep/ COBAS® TaqMan® HCV Test, v2.0
COBAS® TaqMan HCV Test version 2.0 For Use With The High Pure System
Roche Molecular Systems, Inc.
Pleasanton, CA 94588
Change to add an alternate supplier for a critical raw material.
P060040/S029
8/5/13
Thoratec® HeartMate II® Ventricular Assist System (LVAS) Thoratec Corporation
Pleasanton, CA 94588
Addition of Thoratec Corporation as a secondary source for the assembly of the 14V battery clips for the Thoratec® HeartMate® II Ventricular Assist System (LVAS).
P070008/S045
8/14/13
ENTOVIS, ERIA, STRATOS CRT-Ps BIOTRONIK, Inc.
Lake Oswego, OR 97035
Implement a new ethylene oxide sterilization cycle at a contract sterilization site.
P070015/S113
8/27/13
XIENCE V® and Xience nano® Everolimus Eluting Coronary Stent
Systems
Abbott Vascular
Temecula, CA 92590
Change in the test equipment used for the identification and assay of butylated hydroxytoluene (BHT).
P080006/S056
8/22/13
AttainAbility® Lead, Conductor Coil Cleaning Process Medtronic, Inc.
Mounds View, MN 55112
Change in the Conductor Coil Cleaning Process for Attain Ability Lead Models 4196, 4296, and 4396.
P080011/S026
8/6/13
CooperVision comfilcon A Soft (Hydrophilic) Extended-Wear Contact Lenses CooperVision
Pleasanton, CA
94588
Introduction of automated manufacturing equipment.
P080014/S017
8/22/13
Cervista® HPV HR Hologic, Inc.
Marlborough, MA 01752
Change to increase the manufacturing scale for oligonucleotide production.
P080020/S005
8/23/13
Gel-One® Seikagaku Corporation
Tokyo, Japan
100-0005
Use of manufacturing equipment for development use.
P080025/S053
8/1/13
SNS Bowel INS InterStim Family Medtronic Neuromodulation
Minneapolis, MN 55432
Change to reduce the hybrid production burn-in time for the  impacted products.
P080026/S009
8/20/13
Abbott RealTime HBV Abbott Molecular, Inc.
Des Plaines, IL 60018
Change to the manufacturing process for oligonucleotides and the addition of two new suppliers for a raw material.
P080030/S010
8/28/13
iStent Trabecular Micro-Bypass Stent System Glaukos Corporation
Laguna Hills,  CA 92653
Eliminate compressed air cleaning of the package trays and addition of an alternate tray vendor.
P090003/S026
8/22/13
Express® LD Iliac Premounted Stent System Boston Scientific Corporation
Maple Grove, MN 55311
Change to the pre-electropolish laser cut dimensions for the 57mm long small vessel (SV) and large vessel (LV) stents.
P090013/S108
8/12/13
Revo MRI IPG Medtronic, Inc.
Mounds View, MN 55112
Change for an incoming material acceptance procedure for underfill cure epoxy.
P090013/S109
8/22/13
REVO MRI Implantable Pulse Generator Medtronic, Inc.
Mounds View, MN 55112
Alternate suppliers for molded silicone components.
P090018/S023
8/27/13
Esteem System Envoy Medical Corporation
Saint Paul,  MN
55110
Additional manufacturing location for the MedCEM cement.
P100017/S007
8/20/13
Abbott RealTime HCV Abbott Molecular, Inc.
Des Plaines, IL 60018
Change to the manufacturing process for oligonucleotides and the addition of two new suppliers for a raw material.
P100020/S009
8/21/13
cobas® HPV Test Roche Molecular Systems, Inc.
Pleasanton, CA 94588
Change to add an alternate supplier for a critical raw material.
P100024/S005
8/28/13
HER2 CISH pharmDx Dako Denmark A/S
Glostrup, Denmark
DK-2600
Additional probe DNA labeling option for labeling DNA pools.
P100041/S035
8/2/13
Edwards SAPIEN Transcatheter Heart and Transfemoral
Accessories
Edwards Lifesciences, LLC
Irvine, CA
92614
Replacement of a disinfectant for non-product contact surfaces.
P100041/S036
8/9/13
Edwards Sapien Transcatheter Heart Valve and Transfemoral
Accessories
Edwards Lifesciences, LLC
Irvine, CA
92614
Change to the quality inspection sampling plan for the RetroFlex Balloon Catheter Guidewire shaft.
P100047/S028
8/2/13
HeartWare Ventricular Assist System HeartWare, Inc.
Miami Lakes, FL 33014
Use of an additional laser workstation for implementation of weld tapering and laser smoothing processes for the device impeller.
P110010/S007
8/21/13
PROMUS Element Plus Everolimus-Eluting Coronary Stent System Boston Scientific
Natick, MA
01760
Add controls and extend existing functionality to the Carton Labeling and Carton Component Verification (CCV) workstep.
P110013/S022
8/28/13
Resolute Integrity Zotarolimus-Eluting Coronary Stent System Medtronic Vascular
Santa Rosa, CA 95403
Modify the process controls related to the packaging sealed seam.
P110013/S023
8/29/13
Resolute Integrity Over-the-Wire Zotarolimus-Eluting Coronary Stent System Medtronic Vascular
Santa Rosa, CA 95403
Introduce an alternative building for the manufacture of the MicroTrac OTW delivery system within the same approved manufacturing facility.
P110019/S051
8/27/13
XIENCE Prime® Everolimus Eluting Coronary Stent System Abbott Vascular
Temecula, CA 92590
Change in the test equipment used for the identification and assay of butylated hydroxytoluene (BHT).
P110020/S007
8/21/13
cobas® 4800 BRAF V600 Mutation Test Roche Molecular Systems, Inc.
Pleasanton, CA 94588
Change to add an alternate supplier for a critical raw material.
P110021/S021
8/2/13
Edwards SAPIEN Transcatheter Heart Valve Edwards Lifesciences, LLC
Irvine, CA
92614
Replacement of a disinfectant for non-product contact surfaces.
P110021/S22
8/9/13
Edwards Sapien Transcatheter Heart Valve and Transfemoral and
Transapical Accessories
Edwards Lifesciences, LLC
Irvine, CA
92614
Change to the quality inspection sampling plan for the RetroFlex Balloon Catheter Guidewire shaft.
P110028/S009
8/27/13
Absolute Pro Vascular Self-Expanding Stent System Abbott Vascular
Santa Clara, CA 95054
Change to the electropolish solution used in the manufacture of the stents of the devices.
P110029/S012
8/8/12
ARCHITECT HBsAg Qualitative and HBsAg Qualitative Confirmatory Abbott Laboratories, Diagnostics
Abbott Park, IL 60064
Change to the test method for the HBsAg Confirmatory Standards.
P110035/S018
8/15/13
Epic™ Vascular Self-Expanding Stent System Boston Scientific Corporation
Maple Grove, MN 55311
Update the current software on the Epic Wetline Electropolishing System.
P110037/S007
8/21/13
COBAS® AmpliPrep/COBAS® TaqMan® CMV Test Roche Molecular Systems, Inc.
Pleasanton, CA 94588
Change to add an alternate supplier for a critical raw material.
P110042/S013
8/22/13
Subcutaneous Implantable Defibrillator
(S-ICD) System
Cameron Health, Inc.
San Clemente, CA 92673
Perform receiving and inspection activities for certain components and accessories used in the Cameron Health, Inc. S-ICD System at Boston Scientific Corporation's manufacturing facility located in St Paul, Minnesota.
P120005/S007
8/9/13
Dexcom G4 Platinum Continuous Glucose Monitoring System Dexcom, Inc.
San Diego, CA 92121
Add an alternate Dexcom supplier of a component used in the G4 Platinum Continuous Glucose Monitoring System.
P120005/S008
8/21/13
Dexcom G4™ PLATINUM Continuous Glucose Monitoring System Dexcom, Inc.
San Diego, CA 92121
Addition of new gowning rooms.
P120005/S010
8/19/13
Dexcom G4 PLATINUM Continuous Glucose Monitoring System Dexcom, Inc.
San Diego, CA 92121
Addition of a -20°C upright laboratory freezer to the sensor manufacturing equipment.
P120012/S001
8/1/13
Abbott RealTime HCV Genotype II Abbott Molecular Inc.
Des Plaines, IL 60018
Change to the sampling plan for the reagent vial filling procedure.
P120012/S002
8/13/13
Abbott RealTime HCV Genotype II Abbott Molecular, Inc.
Des Plaines, IL 60018
Change to an in-process test method for a component of the Abbott RealTime HCV Genotype II.
P120012/S003
8/20/13
Abbott RealTime HCV Genotype II Abbott Molecular, Inc.
Des Plaines, IL 60018
Change to the manufacturing process for oligonucleotides and the addition of two new suppliers for a raw material.
P120019/S001
8/21/13
cobas® EGFR Mutation Test Roche Molecular Systems, Inc.
Pleasanton, CA 94588
Change to add an alternate supplier for a critical raw material.

Summary of PMA Originals & Supplements Approved
Originals: 4                                                                 
Supplements: 73                                                                     

Summary of PMA Originals Under Review
Total Under Review: 55                                            
Total Active: 21                                                                     
Total On Hold: 34                                                                                          

Summary of PMA Supplements Under Review
Total Under Review: 572                                                      
Total Active: 404                                                                   
Total On Hold: 168                                                                                        

Summary of All PMA Submissions Received
Originals: 0                                                                                                                             
Supplements: 77                                                                     

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 73                                                      
Number of Denials: 0                                                 
Average Days Fr Receipt to Decision (Total Time): 158.7      
FDA Time: 110.7 Days     MFR Time: 48.0 Days

Topics

Advertisement

Share this Story

X
You may login with either your assigned username or your e-mail address.
The password field is case sensitive.
Loading