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PMA Final Decisions for September 2012

Fri, 11/30/2012 - 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 APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P100003
9/28/12
Secure-C Artificial Cervical DiscGlobus Medical, Inc.
Audubon, PA
19403
Approval for the Secure-C Artificial Cervical Disc. 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 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 as compared to adjacent levels. The SECURE®-C Cervical Artificial Disc is implanted using an anterior approach. Patients should have failed at least 6 weeks of conservative treatment prior to implantation of the SECURE®-C Cervical Artificial Disc.
P110006
9/18/12
somo-v® Automated Breast Ultrasound System (ABUS)U-Systems, Inc.
Sunnyvale, CA
94085
Approval for the somo-v®:
Automated Breast Ultrasound System (ABUS). This device is indicated as an adjunct to mammography for breast cancer screening in asymptomatic women for whom screening mammography findings are normal or benign (BI-RADS Assessment Category 1 or 2), with dense breast parenchyma (BI-RADS Composition/ Density 3 or 4) and have not had previous clinical breast intervention. The device is intended to increase breast cancer detection in the described patient population.
P110038
9/21/12
Relay® Thoracic Stent-Graft with Plus Delivery SystemBolton Medical, Inc.
Sunrise, FL
33325
Approval for the Relay® Thoracic Stent-Graft with Plus Delivery System. This device is indicated for the endovascular repair of fusiform aneurysms and saccular aneurysms/ penetrating atherosclerotic ulcers in the descending thoracic aorta in patients having appropriate anatomy, including:
1) Iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices and/or accessories;
2) Non-aneurysmal aortic neck diameter in the range of 19 - 42 mm; and
3) Non-aneurysmal proximal aortic neck lengths between 15 and 25 nun and distal aortic neck lengths between 25 and 30 mm depending on the diameter stent-graft required
P110042
9/28/12
Subcutaneous Implantable Defibrillator (S-ICD®) SystemCameron Health, Inc.
San Clemente, CA
92673
Approval for the Subcutaneous Implantable Defibrillator (S-ICD®) System. This device is indicated to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with antitachycardia pacing.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P840001/S199
9/6/12
180-Day
Medtronic Implantable Neurostimulators for Spinal Cord StimulationMedtronic Neuromodulation
Minneapolis, MN
55432
Approval for a manufacturing site located at Medtronic Neuromodulation in Minneapolis, Minnesota.
P840001/S221
9/14/12
Real-Time
Spinal Cord Stimulation ExtensionMedtronic Neuromodulation
Minneapolis, MN
55432
Approval for minor modifications to the package dimensions, the inner tray and the retainer lid. Also requested was a package material change from Polyvinyl Chloride (PVC) to Polyethylene Terephthalate Glycol (PETG) for the outer tray, the inner tray and the retainer lid.
P880086/S221
9/6/12
Real-Time
Affinity/Integrity/ Victory/Zephyr/ Accent Family of PacemakersSt. Jude Medical, Inc.
Sunnyvale, CA
94086
Approval for an update to the pace and sense integrated circuit.
P890003/S251
9/12/12
180-Day
DDMA SoftwareMedtronic, Inc.
Mounds View, MN
55112
Approval for the use of recently approved software 9995 version 7.4 and associated DDMA software 2491 with recently approved device models D264VRM and D204VRM.
P890003/S258
9/25/12
Real-Time
CareLink Monitor, CardioSight Reader Monitor,
CareLink Express Monitor
Medtronic, Inc.
Mounds View, MN
55112
Approval for firmware updates to the Model 2490C Medtronic CareLink Remote Home Monitor, the Model 2020A Medtronic CardioSight Reader, and the Model 2020B CareLink Express Monitor.
P900060/S049
9/10/12
135-Day
Carbomedics Prosthetic Heart ValveSorin Group USA, Inc.
Arvada, CO
80004
Approval to add equipment to the Pyrolytic Carbon Coating Process.
P910023/S298
9/6/12
180-Day
Ellipse DR, Ellipse VR, Fortify Assura DR and Fortify Assura VR ICDsSt. Jude Medical
Sylmar, CA
91342
Approval for a manufacturing site located at St. Jude Medical Operations Malaysia (SJM-MYPE) in Penang, Malaysia.
P910056/S011
9/4/12
Real-Time
enVista® Hydrophobic Acrylic Intraocular LensBausch & Lomb, Inc.
Aliso Viejo, VA
92656
Approval for changes to the directions for use (DFU) to specify that the enVista MX60 lens is approved for use with the Medicel Accuject 2.6 injector set, or other injector sets that specifically identify the enVista MX60 lens in the cleared labeling.
P910077/S123
9/25/12
Real-Time
LATITUDE PATIENT MANAGEMENT SYSTEM Application Server Software v7.03.0 1 on LATITUDE System ServerBoston Scientific Corporation
St. Paul, MN
55112
Approval for the LATITUDE PATIENT MANAGEMENT SYSTEM Application Server Software v7.03.0 1 on LATITUDE System Server (Model 6488).
P950022/S079
9/13/12
180-Day
Durata LeadsSt. Jude Medical, CRMD
Sylmar, CA
91342
Approval for design changes to the helix-shaft subassembly of market approved Tendril Models 1882, 1888, 1988, 2088 and Durata Models 7120Q, 7121Q, 7122Q, 7120, 7121, 7122, 7130, and 7131 leads for improved manufacturability and cost.
P950037/S111
9/24/12
Real-Time
Reocor S/D External PacemakerBiotronik, Inc.
Lake Oswego, OR
97035
Approval for a change to the low impedance alarm and other minor changes.
P960013/S068
9/13/12
180-Day
Tendril LeadsSt. Jude Medical, CRMD
Sylmar, CA
91342
Approval for design changes to the helix-shaft subassembly of market approved Tendril Models 1882, 1888, 1988, 2088 and Durata Models 7120Q, 7121Q, 7122Q, 7120, 7121, 7122, 7130, and 7131 leads for improved manufacturability and cost.
P960016/S039
9/10/12
Real-Time
Safire™ Cardiac Ablation System CatheterSt. Jude Medical
Minnetonka, MN
55345
Approval for minor design modifications to the pinion gear component.
P970029/S021
9/13/12
Special
TMR2000 Holmium Laser SystemCardiogenesis
Kennesaw, GA
30144
Approval for changes to the instructions for use to clarify the device description, warnings, adverse effects and device operating instructions.
P970054/S009
9/5/12
180-Day
Biotrin International’s Parvovirus B19 IgG Enzyme ImmunoassayBiotrin International, Ltd.
Dublin, Ireland
Approval for a manufacturing site located at Biotrin International LTD in Dublin, Ireland.
P970055/S010
9/5/12
180-Day
Biotrin International’s Parvovirus B19 IgM Enzyme ImmunoassayBiotrin International, Ltd.
Dublin, Ireland
Approval for a manufacturing site located at Biotrin International LTD in Dublin, Ireland.
P970058/S025
9/21/12
180-Day
ImageChecker M5000DHologic, Inc.
Santa Clara, CA
95054
Approval for improvements in the CAD algorithm, updated digital test database and support for GE Senographe Essential FFDM.
P980016/S361
9/10/12
180-Day
Protecta ICD; Protecta DF4 ICD; Protecta XT ICD; and Protecta XT DF4 ICD
 
Medtronic, Inc.
Mounds View, MN
55112
Approval for the Protecta ICD Models D334DRG, D334VRG; Protecta DF4 ICD Models D334DRM, D334VRM; Protecta XT ICD Models D314DRG, D314VRG; Protecta XT DF4 ICD; Models D314DRM; and D314VRM.
P980016/S362
9/12/12
180-Day
Application Software, Maximo II DF4 ICD, Secura DF4 ICDMedtronic, Inc.
Mounds View, MN
55112
Approval for the use of recently approved software 9995 version 7.4 and associated DDMA software 2491 with recently approved device models D264VRM and D204VRM.
P980016/S381
9/25/12
Real-Time
Entrust/Virtuoso/
Protecta, CareLink Monitor, Cardiosight
Reader Monitor, CareLink Express Monitor
Medtronic, Inc.
Mounds View, MN
55112
Approval for firmware updates to the Model 2490C Medtronic CareLink Remote Home Monitor, the Model 2020A Medtronic CardioSight Reader, and the Model 2020B CareLink Express Monitor.
P980035/S290
9/25/12
Real-Time
Enrythm, CardioSight Reader Monitor, CareLink Express MonitorMedtronic, Inc.
Mounds View, MN
55112
Approval for firmware updates to the Model 2490C Medtronic CareLink Remote Home Monitor, the Model 2020A Medtronic CardioSight Reader, and the Model 2020B CareLink Express Monitor.
P980040/S035
9/12/12
180-Day
TECNIS OptiBlue Intraocular Lens (IOL), and TECNIS OptiBlue 1-Piece IOLAbbott Medical Optics, Inc.
Santa Ana, CA
92705
Approval for the addition of two additives (i.e., 2-(3’-t-butyl-2’-hydroxy-5’-vinyl-phenyl)-5-chlorobenzotriazole) (UVAM) and yellow dye) to the SENSAR soft acrylic IOLs (Models ZA9003 and ZCB00).
P000012/S036
9/18/12
135-Day
COBAS® AMPLICOR® Hepatitis C Virus Test version 2.0 and COBAS® AmpliPrep/
COBAS® AMPLICOR® HCV Test Version 2.0
Roche Molecular Systems, Inc.
Pleasanton, CA
94588
Approval for the manufacturing changes to the DNA synthesizer instrument platform for the vialed master mix and probe reagent components.
P000023/S008
9/6/12
135-Day
TMJ Fossa-Eminence and Condylar Prosthesis SystemTMJ Medical
Golden, CO
80401
Approval for changes in degreasing solvent, cutting/machine lubricants and packaging equipment.
P000035/S008
9/6/12
135-Day
TMJ Fossa-Eminence Prosthesis SystemTMJ Medical
Golden, CO
80401
Approval for changes in degreasing solvent, cutting/machine lubricants and packaging equipment.
P000036/S011
9/5/12
135-Day
DermagraftAdvanced BioHealing, Inc.
San Diego, CA
92121
Approval for the qualification of an alternate supplier for a critical device component.
P010015/S175
9/25/12
Real-Time
InSync, Consulta and Syncra Family of IPGs, CardioSight Reader Monitor, CareLink Express MonitorMedtronic, Inc.
Mounds View, MN
55112
Approval for firmware updates to the Model 2490C Medtronic CareLink Remote Home Monitor, the Model 2020A Medtronic CardioSight Reader, and the Model 2020B CareLink Express Monitor.
P010020/S024
9/4/12
180-Day
AMS Acticon™ NeosphincterAmerican Medical Systems, Inc.
Minnetonka, MN
55343
Approval for modifications to the design specifications and manufacturing process of the AMS Acticon™ Control Pump, a component of the device.
P010031/S305
9/17/12
180-Day
Cardiac Resynchronization Therapy Defibrillator
(CRT-D)
Medtronic, Inc.
Mounds View, MN
55112
Approval of the post-approval study protocol.
P010031/S314
9/10/12
180-Day
Protecta CRT-D; Protecta DF4 CRT-D; Protecta XT
CRT-D; Protecta XT DF4 CRT-D
Medtronic, Inc.
Mounds View, MN
55112
Approval for Protecta CRT-D Model D334TRG; Protecta DF4 CRT-D; Model 334TRM: Protecta XT CRT-D Model D314TRG; and Protecta XT DF4 CRT-D Model D314TRM.
P010031/S334
9/25/12
Real-Time
Concerto/Protecta, CareLink Monitor, CardioSight Reader
Monitor, CareLink Express Monitor
Medtronic, Inc.
Mounds View, MN
55112
Approval for firmware updates to the Model 2490C Medtronic CareLink Remote Home Monitor, the Model 2020A Medtronic CardioSight Reader, and the Model 2020B CareLink Express Monitor.
P010032/S058
9/14/12
Real-Time
Eon Mini LE Charger and Eon Mini LE Charging SystemSt. Jude Medical
Plano, TX
75024
Approval for the modification to the Model 3721 Eon Mini Charging System. The device, as modified, will be marketed under the trade name Model 3720 Eon mini LE Charger and Model 3722 Eon mini LE Charging System and is indicated as an aid in the management of chronic pain of the trunk and/or limbs, including unilateral pain associated with any of the following: failed back surgery syndrome, and chronic low back/leg pain.
P010047/S021
9/5/12
Real-Time
NeoMend ProGel Pleural Air Leak SealantNeoMend, Incorporated
Irvine, CA
92618
Approval for modifications to the Push Rod (C-00286), End Cap (C-00280) and Outer Housing (C-00279) components of the Applicator Kit and associated minor labeling changes.
P020009/S088
9/27/12
135-Day
Express 2 Monorail and OTW Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Approval for a modified configuration of the carrier coil used in product packaging.
P020045/S045
9/21/12
Real-Time
7F Freezor Cardiac CryoAblation Catheter, Cryoconsole,
7F Freezor Xtra Surgical Device and Cryoconsole and
9F Freezor MAX Surgical Catheter and Cryoconsole
Medtronic CryoCath, LP
Kirkland, Quebec
Canada
H9H 5H3
Approval for modifications to the firmware and software which is upgraded from version 4.03 to 4.04.080 for the devices.
P020050/S008
9/7/12
Real-Time
ALLEGRETTO WAVE® EYE-Q Excimer Laser SystemAlcon Laboratories, Inc.
Fort Worth, TX
76134
Approval for introduction of a new notebook computer model (Toshiba Tecra A11 ) to replace the current notebook model (Toshiba Tecra M10) which is being phased out by the manufacturer. This will require a change in the operating system from Windows 2000 to Windows XP Service Pack 2 as the new notebook computer will not be supported by the old system.
P030008/S008
9/7/12
Real-Time
ALLEGRETTO WAVE® EYE-Q Excimer Laser SystemAlcon Laboratories, Inc.
Fort Worth, TX
76134
Approval for introduction of a new notebook computer model (Toshiba Tecra A11 ) to replace the current notebook model (Toshiba Tecra M10) which is being phased out by the manufacturer. This will require a change in the operating system from Windows 2000 to Windows XP Service Pack 2 as the new notebook computer will not be supported by the old system.
P030035/S099
9/6/12
Real-Time
Frontier/Frontier II/ Anthem Family of CRT-PsSt. Jude Medical, Inc.
Sunnyvale, CA
94086
Approval for an update to the pace and sense integrated circuit.
P030054/S227
9/6/12
180-Day
Quadra Assura and Unify Assura
CRT-Ds
St. Jude Medical
Sylmar, CA
91342
Approval for a manufacturing site located at St. Jude Medical Operations Malaysia (SJM-MYPE) in Penang, Malaysia.
P040016/S091
9/27/12
135-Day
VeriFLEX (Liberté) Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Approval for a modified configuration of the carrier coil used in product packaging.
P040023/S024
9/6/12
Special
Duraloc Option Ceramic Hip SystemDePuy Orthopaedics, Incorporated
Warsaw, IN
46581
Approval for the addition of an independent inspector to perform visual check of the S-ROM femoral stem component sterile packaging.
P040033/S018
9/11/12
180-Day
Birmingham Hip Resurfacing (BHR) SystemSmith & Nephew, Inc.
Memphis, TN
38116
Approval for a manufacturing site located in Warwick, United Kingdom.
P050027/S004
9/10/12
Special
Karl Storz Photodynamic
D-Light C (PDD) System
Karl Storz Endoscopy-America, Inc.
El Segundo, CA
90245
Approval of corrections to the Ethylene Oxide (EtO) sterilization instructions contained in the PDD Camera Heads instruction card, Hopkins II PDD Telescopes instruction manual and Tricam SL II Camera Control Unit instruction manual.
P050028/S023
9/18/12
135-Day
COBAS® TaqMan HBV Test For Use With The High Pure System and COBAS®
AmpliPrep/ COBAS® TaqMan® HBV Test version 2.0
Roche Molecular Systems, Inc.
Pleasanton, CA
94588
Approval for the manufacturing changes to the DNA synthesizer instrument platform for the vialed master mix and probe reagent components.
P050037/S033
9/25/12
Real-Time
Radiesse®Merz Aesthetics, Incorporation
Franksville, WI
53126
Approval to extend the labeled shelf life of the 3.0cc product fill volume Radiesse from 6 months to 24 months.
P050044/S023
9/25/12
Special
VitagelStryker Orthobiologics
Malvern, PA
19355
Approval for the following two changes to the labeling instructions for use for the VitaPrep Plasma Separator: 1) inclusion of warning statement: "Always wear well fitting gloves when handling VitaPrep” and 2) inclusion of instructions: "Assure there is no blood in the Luer connection. If blood is present, carefully clear the area of residual blood.”
P050052/S036
9/25/12
Real-Time
Radiesse®Merz Aesthetics, Incorporated
Franksville, WI
53126
Approval to extend the labeled shel f life of the 3.0cc product fill volume Radiesse from 6 months to 24 months.
P060002/S024
9/27/12
135-Day
Bard FLAIR Endovascular Stent GraftBard Peripheral Vascular, Inc.
Tempe, AZ
85281
Approval for automation of an inspection step.
P060006/S030
9/27/12
135-Day
Express SD Renal Monorail Premounted Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Approval for a modified configuration of the carrier coil used in product packaging.
P060019/S022
9/7/12
Real-Time
Therapy Cool Path Ablation CathetersSt. Jude Medical
Irvine, CA
92614
Approval for a design modification to the bond between that catheter shaft and the extension tubing. Specifically, to change the adhesive from loctite to urethane and to modify the contact hole from a circular to an octagonal shape.
P060023/S002
9/13/12
135-Day
BRYAN Cervical DiscMedtronic Sofamor Danek USA, Inc.
Memphis, TN
38132
Approval for a change to the injection molding process.
P060030/S024
9/18/12
135-Day
COBAS® AmpliPrep/
COBAS® TaqMan® HCV Test and COBAS® TaqMan HCV Test
version 2.0 For Use With The High Pure System
Roche Molecular Systems, Inc.
Pleasanton, CA
94588
Approval for the manufacturing changes to the DNA synthesizer instrument platform for the vialed master mix and probe reagent components.
P070006/S008
9/5/12
Real-Time
T-SPOT® .TB TestOxford Immunotec, Ltd.
Toms River, NJ
08754
Approval for a design change, for a larger reagent volume format for the T-Cell Xtend® reagent, an accessory to the T-SPOT® .TB Test, to increase the volume from 3 X 2mL vials in a pack to a 50mL bottle.
P070014/S030
9/27/12
135-Day
LifeStent Vascular Stent SystemsBard Peripheral Vascular, Inc.
Tempe, AZ
85281
Approval for automation of an inspection step.
P070014/S033
9/12/12
Special
LifeStent Vascular Stent SystemC.R. Bard, Inc.
Tempe, AZ
85281
Approval for the separation of the manufacturing and inspection responsibilities for the manual press process.
P070015/S070
9/7/12
180-Day
Xience V Everolimus-Eluting Coronary Stent SystemAbbott Vascular
Temecula, CA
92591
Approval for a manufacturing site located at Abbott Nutrition in Sligo, Ireland.
P070015/S087
9/14/12
180-Day
XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent SystemAbbott Vascular, Inc.
Santa Clara, CA
95054
Approval to update the product labeling contained in the Instructions for Use (IFU) and patient guide for the XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent System and for the XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System. These updates specifically included longer term follow-up data to all applicable clinical trials for the devices.
P070015/S088
9/10/12
135-Day
XIENCE V/ XIENCE Everolimus-Eluting Coronary Stent SystemAbbott Vascular
Temecula, CA
92591
Approval for transferring the testing of Total Organic Carbon (TOC) from a contract laboratory to Abbott Vascular in Temecula, California.
P070015/S094
9/19/12
180-Day
XIENCE V®/ XIENCE nano™ Everolimus-Eluting Coronary Stent SystemAbbott Vascular
Temecula, CA
92591
Approval to change the coating integrity specification for the 28 mm length stents to align with that of the 33 mm and 38 mm stents for the XIENCE family of products.
P070026/S007
9/6/12
Special
DePuy Ceramax Ceramic Total Hip SystemDePuy Orthopaedics, Incorporated
Warsaw, IN
46581
Approval for the addition of an independent inspector to perform visual check of the S-ROM femoral stem component sterile packaging.
P080007/S011
9/27/12
135-Day
E-LUMINEXX Vascular StentBard Peripheral Vascular, Inc.
Tempe, AZ
85281
Approval for automation of an inspection step.
P080026/S003
9/26/12
135-Day
RealTime HBV AssayAbbott Molecular, Inc.
Des Plaines, IL
60018
Approval for a change from a manual assembly system to an automated process for kit packaging.
P100010/S018
9/21/12
Real-Time
Arctic Front Cardiac CryoAblation Catheters, Freezor MAX CryoAblation Catheter, Cryoconsole, Manual Retraction Kit and AccessoriesMedtronic CryoCath, LP
Kirkland, Quebec
Canada
H9H 5H3
Approval for modifications to the firmware and software which is upgraded from version 4.03 to 4.04.080 for the device.
P090002/S005
9/6/12
Special
Pinnacle CoMplete Acetabular Hip SystemDePuy Orthopaedics, Incorporated
Warsaw, IN
46581
Approval for the addition of an independent inspector to perform visual check of the S-ROM femoral stem component sterile packaging.
P090013/S072
9/25/12
Real-Time
Revo MRI, CardioSight Reader Monitor, CareLink Express MonitorMedtronic, Inc.
Mounds View, MN
55112
Approval for firmware updates to the Model 2490C Medtronic CareLink Remote Home Monitor, the Model 2020A Medtronic CardioSight Reader, and the Model 2020B CareLink Express Monitor.
P100010/S018
9/21/12
Real-Time
Arctic Front Cardiac CryoAblation Catheters; Freezor MAX CryoAblation Catheter; Cryoconsole; Manual Retraction Kit; and AccessoriesMedtronic CryoCath, LP
Kirkland, Quebec
Canada
H9H 5H3
Approval for modifications to the firmware and software which is upgraded from version 4.03 to 4.04.080 for the device.
P100013/S003
9/19/12
Real-Time
EXOSEAL™ Vascular Closure DeviceCordis Corporation
Miami Lakes, FL
33014
Approval for the patient brochure.
P100017/S002
9/27/12
135-Day
RealTime HCV AssayAbbott Molecular, Inc.
Des Plaines, IL
60018
Approval for a change from a manual assembly system to an automated process for kit packaging.
P100023/S053
9/27/12
Real-Time
ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Approval for removal of the ball from the tip of the corewire which is located between the inner and outer lumen of the Stent Delivery System. The device, as modified, will be marketed under the trade PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System and ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System and are indicated for improving luminal diameter in patients with symptomatic heart disease or documented silent ischemia due to de novo lesions in native coronary arteries >2.25 mm to <4.00 mm in diameter in lesions <34 mm in length, and for improving luminal diameter for the treatment of de novo lesions in native coronary arteries >2.25 mm to < 4.00 mm in diameter in lesions < 3 4 mm in length, respectively
P100025/S001
9/5/12
180-Day
BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) and Pediatric Urea Hydrolysis
Rate Calculation Application (pUHR-CA), Version 1.0
Otsuka America Pharmaceutical, Inc.
Rockville, MD
20850
Approval for packaging changes for the BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) and Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), Version 1.0. The packaging changes consist of new kit and shipper cartons along with new labeling on each of these cartons.
P100044/S001
9/21/12
180-Day
Propel™ Mini Sinus ImplantIntersect ENT
Palo Alto, CA
94303
Approval for a shortened version of the drug-eluting sinus stent. The device, as modified, will be marketed under the trade name Propel™ Mini Sinus Implant and is indicated for use in patients ≥ 18 years of age following ethmoid sinus surgery to maintain patency, thereby reducing the need for post-operative intervention such as surgical adhesion lysis and/or use of oral steroids. The Propel Mini Sinus Implant separates mucosal tissues, provides stabilization of the middle turbinate, prevents obstruction by adhesions, and reduces edema.
P110010/S028
9/27/12
Real-Time
PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent
System
Boston Scientific Corporation
Maple Grove, MN
55311
Approval for removal of the ball from the tip of the corewire which is located between the inner and outer lumen of the Stent Delivery System. The device, as modified, will be marketed under the trade PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System and ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System and are indicated for improving luminal diameter in patients with symptomatic heart disease or documented silent ischemia due to de novo lesions in native coronary arteries >2.25 mm to <4.00 mm in diameter in lesions <34 mm in length, and for improving luminal diameter for the treatment of de novo lesions in native coronary arteries >2.25 mm to < 4.00 mm in diameter in lesions < 3 4 mm in length, respectively
P110016/S001
9/13/12
135-Day
Therapy Cool Path Duo Ablation Catheter, Safire BLU Duo Ablation Catheter, and Cardiac Ablation GeneratorSt. Jude Medical – Irvine Biomedical
Irvine, CA
92614
Approval for an alternate vendor to supply printed circuit boards for the 1500T9-CP v1.6 generator.
P110016/S004
9/7/12
Real-Time
Therapy Cool Path Duo Ablation CathetersSt. Jude Medical
Irvine, CA
92614
Approval for a design modification to the bond between that catheter shaft and the extension tubing. Specifically, to change the adhesive from loctite to urethane and to modify the contact hole from a circular to an octagonal shape.
P110019/S009
9/14/12
180-Day
XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent SystemAbbott Vascular, Inc.
Santa Clara, CA
95054
Approval to update the product labeling contained in the Instructions for Use (IFU) and patient guide for the XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent System and for the XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System. These updates specifically included longer term follow-up data to all applicable clinical trials for the devices.
P110019/S011
9/10/12
135-Day
XIENCE Prime LL Everolimus-Eluting Coronary Stent SystemAbbott Vascular
Temecula, CA
92591
Approval for transferring the testing of Total Organic Carbon (TOC) from a contract laboratory to Abbott Vascular in Temecula, California.
P110019/S020
9/19/12
180-Day
XIENCE PRIME™/ XIENCE PRIME LL™ Everolimus-Eluting Coronary Stent SystemAbbott Vascular
Temecula, CA
92591
Approval to change the coating integrity specification for the 28 mm length stents to align with that of the 33 mm and 38 mm stents for the XIENCE family of products.
P110020/S003
9/4/12
135-Day
cobas® 4800 BRAF V600 Mutation TestRoche Molecular Systems, Inc.
Pleasanton, CA
94588
Approval for a change in the DNA synthesizer instrument platform for certain vialed master mix and probe reagent components.
P110037/S001
9/5/12
Real-Time
COBAS® AmpliPrep/ COBAS® TaqMan® CMV TestRoche Molecular Systems, Inc.
Pleasanton, CA
94588
Approval for a change to the Test Definition File (TDF). The device, as modified, will be marketed under the trade name COBAS AmpliPrep/COBAS TaqMan CMV Test and is indicated for: COBAS AmpliPrep/COBAS TaqMan CMV Test: The COBAS AmpliPrep/ COBAS TaqMan CMV Test is an in vitro nucleic acid amplification test for the quantitative measurement of cytomegalovirus (CMV) DNA in human EDTA plasma using the COBAS AmpliPrcp Instrument for automated specimen processing and the COBAS TaqMan Analyzer or the COBAS TaqMan 48 Analyzer for automated amplification and detection. The COBAS AmpliPrcp/ COBAS TaqMan CMV Test is intended for usc as an aid in the management of solid-organ transplant patients who arc undergoing anti-CMV therapy. In this population serial DNA measurements can be used to assess virological response to antiviral treatment. The results from the COBAS AmpliPrep/COBAS TaqMan CMV Test must be interpreted within the context of all relevant clinical and laboratory findings. The COBAS AmpliPrep/ COBAS TaqMan CMV Test is not intended for use as a screening test for the presence of CMV DNA in blood or blood products.

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

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P810006/S034
9/14/12
COLLASTAT Absorbable Collagen Hemostatic Sponge, COLLASTAT Absorbable Collagen Hemostatic Agent-Microfibrillar FormIntegra LifeSciences Corporation
Plainsboro, NJ
08536
Change in Chart Recording System.
P810006/S035
9/28/12
CollaStat Absorbable Collagen Hemostatic Sponge
CollaStat Absorbable Collagen Hemostatic Agent-Microfibrillar Form
Integra LifeSciences Corporation
Plainsboro, NJ
08536
Upgrades to the Medical Products Manufacturing Suite.
P840001/S225
9/12/12
Restore Rechargeable/ Restore Prime/Restore Advanced/Prime
Advanced/Restore Ultra/Itrel 4/ Synergy/Synergy Verstirel/Restore
Sensor
Medtronic, Inc.
Minneapolis, MN
55432
Change the acceptance criteria for titanium content in the cables and to add an alternate supplier for the cable braiding and micro-extrusion processes.
P840001/S226
9/13/12
Itrel®, Synergy®, Restore®, Soletra®, Kinetra®, lnterstim® & Enterra®
Neurostimulators
Medtronic Neuromodulation
Minneapolis, MN
55432
Addition of manufacturing equipment at the MPROC-Juncos facility germane to the devices.
P840062/S023
9/14/12
CollaCote, CollaTape and CollaPlug Absorbable Collagen
Wound Dressings for Dental Surgery
Integra LifeSciences Corporation
Plainsboro, NJ
08536
Change in Chart Recording System.
P840062/S024
9/28/12
CollaCote, CollaTape, CollaPlug Absorbable Collagen Wound Dressing for Dental SurgeryIntegra LifeSciences Corporation
Plainsboro, NJ
08536
Upgrades to the Medical Products Manufacturing Suite.
P850010/S031
9/14/12
HELISTAT and HELITENE Absorbable Collagen Hemostatic AgentIntegra LifeSciences Corporation
Plainsboro, NJ
08536
Change in Chart Recording System.
P850010/S032
9/28/12
HeliStat, Helitene Absorbable Collagen Hemostatic AgentsIntegra LifeSciences Corporation
Plainsboro, NJ
08536
Upgrades to the Medical Products Manufacturing Suite.
P850079/S054
9/11/12
Methafilcon A and B Soft Extended Wear Contact LensesCooperVision, Inc.
Pleasanton, CA
94588
Relocation of a manufacturing line and installation of supporting parts.
P850079/S055
9/18/12
Methafilcon A and B Soft Extended Wear Contact LensesCooperVision, Inc.
Pleasanton, CA
94588
Temporary change to the inspection process.
P850079/S056
9/18/12
Methafilcon A and B Soft Extended Wear Contact LensesCooperVision, Inc.
Pleasanton, CA
94588
New manufacturing line.
P860057/S091
9/19/12
Carpentier-Edwards PERIMOUNT Pericardial BioprosthesisEdward Lifesciences, LLC
Irvine, CA
92614
Modify the layout of an isolation clean room.
P870056/S051
9/19/12
Carpentier-Edwards Porcine BioprosthesisEdward Lifesciences, LLC
Irvine, CA
92614
Modify the layout of an isolation clean room.
P870077/S046
9/19/12
Carpentier-Edwards S.A.V. BioprosthesisEdward Lifesciences, LLC
Irvine, CA
92614
Modify the layout of an isolation clean room.
P880086/S222
9/14/12
Accent Family of PacemakersSt. Jude Medical
Sylmar, CA
91342
Clarification of the visual inspection criteria for low voltage pulse generators.
P880086/S224
9/12/12
Accent Family of PacemakersSt. Jude Medical, Inc.
Sylmar, CA
91342`
Alternate supplier for the electromagnetic coil receiver used in the voice coil assembly.
P880086/S225
9/24/12
Family of PacemakersSt. Jude Medical, Inc.
Sylmar, CA
91342
Reduction in the cure time for the room temperature vulcanized adhesive.
P890003/S256
9/10/12
Prodigy IPGMedtronic, Inc.
Mounds View, MN
55112
Update to the battery burn-in process and inspection methods.
P890003/S257
9/19/12
ProdigyMedtronic, Inc.
Mounds View, MN
55112
Addition of a new supplier for packaging materials, and a change to the orientation of an identification number on the packaging
P910001/S061
9/5/12
ELCA Coronary Artherectomy CatheterSpectranetics Corporation
Colorado Springs, CO
80921
Use of additional sterilization chambers at the contract sterilizer.
P910023/S303
9/24/12
Family of ICDsSt. Jude Medical, Inc.
Sylmar, CA
91342
Reduction in the cure time for the room temperature vulcanized adhesive.
P920047/S053
9/21/12
Blazer Prime HTD Temperature Ablation CatheterBoston Scientific Corporation
Maple Grove, MN
55311
Use of new Statistical Process Control software.
P930031/S034
9/6/12
Wallstent Transjugular Portosystemic Shunt (TIPS) Endoprosthesis with
Unistep Plus Delivery System
Boston Scientific Corporation
Maple Grove, MN
55311
Use of new Statistical Process Control software.
P930031/S035
9/21/12
Wallstent Transjugular Portosystemic Shunt (TIPS) Endoprosthesis with
Unistep Plus Delivery System
Boston Scientific Corporation
Maple Grove, MN
55311
Use of new Statistical Process Control software.
P940019/S029
9/6/12
Wallstent Iliac Endoprosthesis with Unistep Plus Delivery SystemBoston Scientific Corporation
Maple Grove, MN
55311
Use of new Statistical Process Control software.
P940019/S030
9/21/12
Wallstent Iliac Endoprosthesis with Unistep Plus Delivery SystemBoston Scientific Corporation
Maple Grove, MN
55311
Use of new Statistical Process Control software.
P950020/S052
9/6/12
Flextome Cutting Balloon Dilation DeviceBoston Scientific Corporation
Maple Grove, MN
55311
Use of new Statistical Process Control software.
P950020/S053
9/7/12
Flextome Cutting BalloonBoston Scientific Corporation
Maple Grove, MN
55311
An alternate supplier for the balloon protector cap component; and minor dimensional changes for the balloon protector cap component.
P950020/S054
9/21/12
Flextome Cutting Balloon Dilation Device (Monorail & Over-the-Wire)Boston Scientific Corporation
Maple Grove, MN
55311
Use of new Statistical Process Control software.
P960009/S115
9/13/12
Itrel®, Synergy®, Restore®, Soletra®, Kinetra®, lnterstim® & Enterra®
Neurostimulators
Medtronic Neuromodulation
Minneapolis, MN
55432
Addition of manufacturing equipment at the MPROC-Juncos facility germane to the devices.
P960009/S154
9/12/12
Activa Tremor Control SystemMedtronic, Inc.
Minneapolis, MN
55432
Change the acceptance criteria for titanium content in the cables and to add an alternate supplier for the cable braiding and micro-extrusion processes.
P960040/S268
9/11/12
Punctua, Energen and Incepta ICDsBoston Scientific Corporation
St. Paul, MN
55112
Addition of an alternate supplier for the tantalum capacitors.
P960040/S269
9/24/12
Teligen. Cognis, lncepta, Energen and Punctua ICDsBoston Scientific Corporation
St. Paul, MN
55112
Update to the acceptance activities for tab length measurement inspection process.
P960042/S041
9/5/12
Spectranetics Laser Sheaths SLSSpectranetics Corporation
Colorado Springs, CO
80921
Use of additional sterilization chambers at the contract sterilizer.
P970003/S151
9/6/12
 
VNS Therapy® Pulse GeneratorsCyberonics, Inc.
Houston, TX
77058
Addition of a fixture for cleaning of a component.
P970003/S152
9/13/12
VNS Therapy SystemCyberonics, Inc.
Houston, TX
77058
Use of alternate Schottky diodes for the VNS Therapy Implantable Pulse Generators and the Programming Wand.
P970004/S140
9/13/12
Itrel®, Synergy®, Restore®, Soletra®, Kinetra®, lnterstim® & Enterra®
Neurostimulators
Medtronic Neuromodulation
Minneapolis, MN
55432
Addition of manufacturing equipment at the MPROC-Juncos facility germane to the devices.
P970051/S095
9/5/12
Nucleus 24 Cochlear Implant SystemCochlear Americas
Centennial, CO
80111
Re-commissioning of a clean room and establishment of a new manufacturing line.
P980016/S374
9/4/12
Protecta ICD, Protecta XT ICDMedtronic, Inc.
Mounds View, MN
55112
Software update to a CD Surge test.
P980016/S377
9/5/12
Maximo II, Protecta, Protecta XT, Secura, Virtuoso II DR/VR ICDsMedtronic, Inc.
Mounds View, MN
55112
Implementation of FACTORY works Release 8.0 and MES Web Services Release 2.1.
P980016/S378
9/19/12
Maximo II, Protecta, Protecta XT, Secura, Virtuosos II DR/VR ICDsMedtronic, Inc.
Mounds View, MN
55112
Updates to the IC wafer probe test specifications and test software.
P980016/S379
9/20/12
Maximo II DF4 CRT-D, Maximo II DF4 ICD, Maximo II ICD, Protecta DF4 ICD, Protecta ICD, Protecta XT DF4 ICD, Protccta XT ICD, Secura DF4, Secura and Virtuoso II DR/VR ICDsMedtronic, Inc.
Mounds View, MN
55112
Update acceptance criteria inspection process for all die locations on all hybrids.
P980016/S380
9/20/12
Protecta and Protecta XT
ICDs
Medtronic, Inc.
Mounds View, MN
55112
Update to the manufacturing test for an integrated circuit (IC) at the supplier location.
P980022/S121
9/13/12
Paradigm® REAL-Time System,
Paradigm® REA L-Time REVEL System, and
Guardian® REAL-Time System
Medtronic MiniMed
Northridge, CA
91325
Reinstatement of the Ayutthaya, Thailand facility as an additional facility for the manufacture of printed circuit board assemblies and stack subassemblies used by Medtronic MiniMed in the production of the Paradigm® REAL-Time Insulin Pump (models MMT-522, MMT-522K, MMT-722, MMT-722K), Paradigm® REAL-Time REVEL Insulin Pump (models MMT-523, MMT-523K, MMT-723, and MMT-723K)) and Guardian® REAL-Time Monitor (CSS7100, CSS7 100K). The Paradigm® REAL-Time Insulin Pump, Paradigm® REAL-Time REVEL Insulin Pump, and Guardian® REAL-Time Monitor are components of the devices.
P980022/S122
9/18/12
Paradigm® REAL-Time System,
Paradigm® REA L-Time REVEL System, and
Guardian® REAL-Time System, CGMS IPro System and CGMS iPro2 System
Medtronic, Inc.
Northridge, CA
91325
Manufacturing process change which will incorporate the addition of process water to a once-diluted batch of platinum plating solution for the Sof-Sensor Glucose Sensors (models MMT-7002 and MMT-7003) that are components of the devices.
P980023/S047
9/24/12
Linox Smart Drug- Eluting Pacing LeadBiotronik, Inc.
Lake Oswego, OR
97035
Adding new labeling software used to print the labels for various devices and accessories.
P980033/S023
9/6/12
Wallstent Venous Endoprosthesis with Unistep Plus Delivery SystemBoston Scientific Corporation
Maple Grove, MN
55311
Use of new Statistical Process Control software.
P980033/S024
9/21/12
Wallstent Venous Endoprosthesis with Unistep Plus Delivery SystemBoston Scientific Corporation
Maple Grove, MN
55311
Use of new Statistical Process Control software.
P980035/S286
9/5/12
Adapta, Adapta L, Adapta S, Sensia L, Sensia, Versa, Advisa DR, Relia
IPGs
Medtronic, Inc.
Mounds View, MN
55112
Implementation of FACTORY works Release 8.0 and MES Web Services Release 2.1.
P980035/S287
9/10/12
Adapta, Adapta L, Adapta S, Sensia L, Sensia, Versa, IPGsMedtronic, Inc.
Mounds View, MN
55112
Update to the battery burn-in process and inspection methods.
P980035/S288
9/19/12
Adapta, Relia and SensiaMedtronic, Inc.
Mounds View, MN
55112
Addition of a new supplier for packaging materials, and a change to the orientation of an identification number on the packaging.
P980035/S289
9/19/12
Advisa DR IPGMedtronic, Inc.
Mounds View, MN
55112
Updates to the IC wafer probe test specifications and test software.
P980044/S014
9/18/12
SUPARTZ®Seikagaku Corporation
Tokyo, Japan
100-0005
Modification of an existing water system.
P000007/S033
9/19/12
Edwards Prima Plus Stentless BioprosthesisEdward Lifesciences, LLC
Irvine, CA
92614
Modify the layout of an isolation clean room.
P000012/S039
9/14/12
COBAS® AMPLICOR® Hepatitis C Virus Test version 2.0 and COBAS® AmpliPrep/
COBAS® AMPLICOR® HCV Test Version 2.0
Roche Molecular Systems, Inc.
Pleasanton, CA
94588
Change to adjust the environmental testing performed at the RMS Branchburg facility.
P000037/S029
9/19/12
On-X Prosthetic Heart ValveOn-X Technologies, Inc.
Austin, TX
78752
Modification to the Limulus Amebocyte Lysate (LAL) test method and procedure.
P010012/S298
9/11/12
Punctua, Energen and Incepta CRT-DsBoston Scientific Corporation
St. Paul, MN
55112
Addition of an alternate supplier for the tantalum capacitors.
P010012/S299
9/24/12
Teligen, Cognis, lncepta, Energen and Punctual
CRT-Ds
Boston Scientific Corporation
St. Paul, MN
55112
Update to the acceptance activities for tab length measurement inspection process.
P010015/S172
9/5/12
Consulta and Syncra CRT-PsMedtronic, Inc.
Mounds View, MN
55112
Increase in a test limit on the feed through assembly at the supplier location.
P010015/S173
9/5/12
Consulta, Syncra CRT-PsMedtronic, Inc.
Mounds View, MN
55112
Implementation of FACTORY works Release 8.0 and MES Web Services Release 2.1.
P010015/S174
9/19/12
Consulta, Syncra CRT-PMedtronic, Inc.
Mounds View, MN
55112
Updates to the IC wafer probe test specifications and test software.
P010031/S327
9/4/12
Protecta CRT-D, Protecta XT CRT-DMedtronic, Inc.
Mounds View, MN
55112
Software update to a CD Surge test.
P010031/S330
9/5/12
Concerto II, Consulta DF4, Maximo II, Protecta, Protecta XT 1CDs and
CRT-Ds
Medtronic, Inc.
Mounds View, MN
55112
Implementation of FACTORY works Release 8.0 and MES Web Services Release 2.1.
P010031/S331
9/19/12
Concerto II CRT-D, Consulta DF4 ICD, Consulta ICD, Maximo II
CRT-D, Protecta CRT-D and Protecta XT CRT-D
Medtronic, Inc.
Mounds View, MN
55112
Updates to the IC wafer probe test specifications and test software.
P010031/S332
9/20/12
Concerto II CRT-D, Consulta DF4 ICD, Consulta ICD,
Maximo II CRT-D, Maximo II DF4 CRT-D, Protecta CRT-D, Protecta DF4 CRT-D, Protecta XT
CRT-D, Protecta XT DF4 CRT-D
Medtronic, Inc.
Mounds View, MN
55112
Update acceptance criteria inspection process for all die locations on all hybrids.
P010031/S333
9/20/12
Protecta and Protecta XT
CRT-Ds
Medtronic, Inc.
Mounds View, MN
55112
Update to the manufacturing test for an integrated circuit (IC) at the supplier location.
P010041/S035
9/19/12
Carpentier-Edwards S.A.V. BioprosthesisEdward Lifesciences, LLC
Irvine, CA
92614
Modify the layout of an isolation clean room.
P020009/S091
9/21/12
Express Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Alternate equipment for dispensing and mixing urethane adhesive.
P020009/S092
9/21/12
Express 2 Coronary Stent System (Monorail & Over-the-Wire)Boston Scientific Corporation
Maple Grove, MN
55311
Use of new Statistical Process Control software.
P020025/S035
9/21/12
Blazer Prime XP Temperature Ablation CatheterBoston Scientific Corporation
Maple Grove, MN
55311
Use of new Statistical Process Control software.
P030017/S141
9/14/12
Precision Spinal Cord Stimulator SystemBoston Scientific Corporation
Valencia, CA
91355
Addition of an alternate supplier for a component of the charger assembly.
P030017/S142
9/26/12
Precision Spinal Cord Stimulator (SCS) SystemBoston Scientific Corporation
Valencia, CA
91355
Update the test systems used for the testing of the Implantable Pulse Generator (IPG) of the device.
P030022/S022
9/6/12
Reflection Ceramic Acetabular Hip SystemSmith & Nephew, Inc.
Memphis, TN
38116
Addition of an alternate vendor for the Anthology Hip Stem porous coating process.
P030031/S047
9/20/12
ThermoCool SF CathetersBiosense Webster, Inc.
Diamond Bar, CA
91765
New test equipment for the devices.
P030035/S100
9/14/12
Anthem Family of PacemakersSt. Jude Medical
Sylmar, CA
91342
Clarification of the visual inspection criteria for low voltage pulse generators.
P030035/S102
9/12/12
Anthem Family of CRT-PsSt. Jude Medical, Inc.
Sylmar, CA
91342`
Alternate supplier for the electromagnetic coil receiver used in the voice coil assembly.
P030035/S103
9/24/12
Family of CRT-PsSt. Jude Medical, Inc.
Sylmar, CA
91342
Reduction in the cure time for the room temperature vulcanized adhesive.
P030054/S231
9/24/12
Family of CRT-DsSt. Jude Medical, Inc.
Sylmar, CA
91342
Reduction in the cure time for the room temperature vulcanized adhesive.
P040003/S012
9/7/12
ExAblate SystemInsightec, Ltd.
Dallas, TX
75244
Change in the manufacturing of the transducer for the ExAblate System from a contract manufacturer to the in-house facility.
P040012/S049
9/21/12
RX Acculink Carotid Stent SystemAbbott Vascular
Santa Clara, CA
95054
Change to the dispensing system for applying controlled amounts of assembly fluids during the manufacturing process.
P040016/S095
9/6/12
VeriFLEX Coronary Stent System (Monorail)Boston Scientific Corporation
Maple Grove, MN
55311
Use of new Statistical Process Control software.
P040016/S096
9/21/12
VeriFLEX (Libertè) Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Alternate equipment for dispensing and mixing urethane adhesive.
P040016/S097
9/21/12
VeriFLEX Coronary Stent System (Monorail & Over-the-Wire)Boston Scientific Corporation
Maple Grove, MN
55311
Use of new Statistical Process Control software.
P050006/S030
9/7/12
Gore Helex Septal OccluderW.L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Redesigned flaring equipment and reduction of the sampling plans for the device lock release force.
P050006/S031
9/27/12
GORE HELEX Septal OccluderW.L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Use of alternate cutting equipment.
P050019/S010
9/6/12
Carotid WALLSTENT Monorail EndoprosthesisBoston Scientific Corporation
Maple Grove, MN
55311
Use of new Statistical Process Control software.
P050028/S026
9/14/12
COBAS® TaqMan HBV Test For Use With The High Pure System and COBAS®
AmpliPrep/ COBAS® TaqMan® HBV Test version 2.0
Roche Molecular Systems, Inc.
Pleasanton, CA
94588
Change to adjust the environmental testing performed at the RMS Branchburg facility.
P050039/S011
9/27/12
Novation Ceramic Articulation Hip SystemExatech, Inc.
Gainesville, FL 32653
Addition of laser marking systems for purposes of the product identification of the mating femoral stems used with the devices.
P060006/S033
9/21/12
Express SD Renal Monorail Premounted Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Use of new Statistical Process Control software.
P060007/S020
9/14/12
ARCHITECT HBsAg/HBsAg ConfirmatoryAbbott Laboratories
Abbott Park, IL
60064
Change to a test method used in the manufacture of the components of the ARCHITECT HBsAg and HBsAg Confirmatory assay, and the ARCHITECT HBsAg Qualitative and HBsAg Qualitative Confirmatory assay.
P060008/S094
9/6/12
TAXUS Libertè Paclitaxel-Eluting Platinum Chromium Coronary Stent
System (Monorail)
Boston Scientific Corporation
Maple Grove, MN
55311
Use of new Statistical Process Control software.
P060008/S095
9/21/12
TAXUS Libertè Paclitaxel-Eluting Coronary Stent
System
Boston Scientific Corporation
Maple Grove, MN
55311
Alternate equipment for dispensing and mixing urethane adhesive.
P060008/S096
9/21/12
TAXUS Libertè Paclitaxel-Eluting Platinum Chromium Coronary Stent
System (Monorail & Over-the-Wire)
Boston Scientific Corporation
Maple Grove, MN
55311
Use of new Statistical Process Control software.
P060030/S028
9/14/12
COBAS® AmpliPrep/
COBAS® TaqMan® HCV Test and COBAS® TaqMan HCV Test
version 2.0 For Use With The High Pure System
Roche Molecular Systems, Inc.
Pleasanton, CA
94588
Change to adjust the environmental testing performed at the RMS Branchburg facility.
P070007/S036
9/21/12
Talent Thoracic Stent Graft SystemMedtronic Vascular
Santa Rosa, CA
95403
Automation of a cutting/sealing step.
P070014/S034
9/21/12
LifeStent Vascular Stent SystemBard Peripheral Vascular, Inc.
Tempe, AZ
85281
Addition of an alternate supplier for tantalum markers.
P070015/S099
9/7/12
XIENCE V and Nano Everolimus Eluting Coronary Stent System
(EECSS)
Abbott Vascular
Temecula, CA
92591
Change to the method used to test for drug release.
P070027/S035
9/21/12
Talent Abdominal Stent Graft with the Xcelerant Hydro Delivery SystemMedtronic Vascular
Santa Rosa, CA
95403
Automation of a cutting/sealing step.
P080006/S043
9/19/12
Attain Ability LeadsMedtronic, Inc.
Mounds View, MN
55112
Addition of a new supplier for packaging materials, and a change to the orientation of an identification number on the packaging.
P080011/S017
9/27/12
Biofinity (Comfilcon A) Soft Extended Wear Contact LensesCooperVision, Inc.
Pleasanton, CA
94588
Addition of an alternate supplier of raw material.
P080012/S006
9/13/12
Prometra Programmable Infusion Pump SystemFlowonix Medical, Inc.
Mount Olive, NJ
07828
New Alternate sub-tier supplier for a component of the device.
P080012/S007
9/11/12
Prometra Programmable Implantable Infusion Pump SystemFlowonix Medical, Inc.
Mt. Olive, NJ
07828
Use of an alternate sub-tier supplier for a component of the device.
P080025/S037
9/13/12
Itrel®, Synergy®, Restore®, Soletra®, Kinetra®, lnterstim® & Enterra®
Neurostimulators
Medtronic Neuromodulation
Minneapolis, MN
55432
Addition of manufacturing equipment at the MPROC-Juncos facility germane to the devices.
P080030/S006
9/18/12
Glaukos Corporation iStent Trabecular Micro-Bypass Stent SystemGlaukos Corporation
Laguna Hills, CA
92653
Addition of a second clean room and to perform in house peel testing.
P090003/S015
9/6/12
Express LD Iliac Premounted Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Use of new Statistical Process Control software.
P090013/S070
9/5/12
Revo MRI IPGMedtronic, Inc.
Mounds View, MN
55112
Implementation of FACTORY works Release 8.0 and MES Web Services Release 2.1.
P090013/S071
9/10/12
Revo MRI IPGMedtronic, Inc.
Mounds View, MN
55112
Update to the battery burn-in process and inspection methods.
P090018/S018
9/28/12
EsteemEnvoy Medical Corporation
Saint Paul, MN
55110
Change to the Ear Insert Tube cleaning process.
P090022/S014
9/20/12
Softec HD, Softec I, Softec HD PS and Softec HDO Intraocular Lenses (IOLs)Lenstec Incorporated
St. Petersburg, FL
33716
Inclusion of two additional steam sterilizer units for the sterilization of the firm's Softec series of IOLs.
P100020/S006
9/14/12
cobas® HPV TestRoche Molecular Systems, Inc.
Pleasanton, CA
94588
Change to adjust the environmental testing performed at the RMS Branchburg facility.
P100021/S020
9/25/12
Endurant and Endurant II Stent Graft SystemsMedtronic Vascular
Santa Rosa, CA
95403
Process change to the spindle hypotube assembly to improve its adhesive properties.
P100023/S049
9/17/12
 
ION Paclitaxel-Eluting Coronary Stent System
 
Boston Scientific Corporation
Maple Grove, MN
55311
Changes to the distal bond process for the stent delivery system.
P100023/S052
9/6/12
ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System
(Monorail)
 
Boston Scientific Corporation
Maple Grove, MN
55311
Use of new Statistical Process Control software.
P100023/S054
9/21/12
ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System
(Monorail & Over-the-Wire)
 
Boston Scientific Corporation
Maple Grove, MN
55311
Use of new Statistical Process Control software.
P100040/S009
9/21/12
Valiant Thoracic Stent Graft with the Captivia Delivery SystemMedtronic Vascular
Santa Rosa, CA
95403
Automation of a cutting/sealing step.
P100041/S014
9/19/12
Edwards SAPIEN Transcatheter Heart ValveEdward Lifesciences, LLC
Irvine, CA
92614
Modify the layout of an isolation clean room.
P110010/S024
9/17/12
PROMUS Element Plus Everolimus-Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Changes to the distal bond process for the stent delivery system.
P110010/S027
9/6/12
PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and OTW)Boston Scientific Corporation
Maple Grove, MN
55311
Use of new Statistical Process Control software.
P110010/S029
9/21/12
PROMUS Element Plus Everolimus-Eluting Platinum Chromium
Coronary Stent System (Monorail & Over-the- Wire)
Boston Scientific Corporation
Maple Grove, MN
55311
Use of new Statistical Process Control software.
P110019/S030
9/7/12
XIENCE PR1ME and PRIME LL Everolimus Eluting Coronary stent
System (EECSS)
Abbott Vascular
Temecula, CA
92591
Change to the method used to test for drug release.
P110020/S005
9/14/12
COBAS 4800 BRAF V600 Mutation TestRoche Molecular, Systems, Inc.
Pleasanton, CA
94558
Change to adjust the environmental testing performed at the RMS Branchburg facility.
P110027/S027
9/6/12
PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail & OTW)Boston Scientific Corporation
Maple Grove, MN
55311
Use of new Statistical Process Control software.
P110029/S004
9/14/12
ARCHITECT HBsAg Qualitative/HBsAg Qualitative ConfirmatoryAbbott Laboratories
Abbott Park, IL
60064
Change to a test method used in the manufacture of the components of the ARCHITECT HBsAg and HBsAg Confirmatory assay, and the ARCHITECT HBsAg Qualitative and HBsAg Qualitative Confirmatory assay (P110029).
P110035/S003
9/21/12
Epic Vascular Self Expanding Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Use of new Statistical Process Control software.
P110037/S002
9/14/12
COBAS® AmpliPrep/ COBAS® TaqMan® CMV TestRoche Molecular Systems, Inc.
Pleasanton, CA
94588
Change to adjust the environmental testing performed at the RMS Branchburg facility.
P110043/S001
9/7/12
Omnilink Elite Vascular Balloon Expandable Stent SystemAbbott Vascular, Inc.
Temecula, CA
92580
New straightness test for cobalt chromium stent tubing.
P110043/S002
9/24/12
Omnilink Elite Vascular Stent SystemAbbott Vascular, Inc.
Temecula, CA
92580
Changes to the extruded tubing process.

Summary of PMA Originals & Supplements Approved
Originals: 4
Supplements: 78

Summary of PMA Originals Under Review
Total Under Review: 57
Total Active: 30
Total On Hold: 27
Number Greater Than 180 Days: 1

Summary of PMA Supplements Under Review
Total Under Review: 581
Total Active: 443
Total On Hold: 138
Number Greater Than 180 Days: 5

Summary of All PMA Submissions Received
Originals: 0
Supplements: 57

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 78
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 145.7
FDA Time: 104.9 Days MFR Time: 40.8 Days

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