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PMA Final Decisions for October 2011

Wed, 11/30/2011 - 6:30am
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.

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
D970012/S089

10/26/11

AMS Model 700 Inflatable Penile ProsthesisAmerican Medical Systems

Minnetonka, MN

55343

Change in the packaging process for the devices.
P780007/S046

10/21/11

Biomedics 38 (Polymacon) Soft (Hydrophilic) Contract LensesCooperVision Incorporated

Pleasanton, CA

94588

Addition of sterilization cycle runs for single blisters, CVI blisters and six pack blisters to sterilizer Fedegari.
P840001/S196

10/21/11

Restore Family of Implantable NeurostimulatorsMedtronic, Inc.

Minneapolis, MN

55432

Implement software updates to the Self Test application of the Next Generation Tester.
P850068/S009

10/14/11

Bausch & Lomb Silsoft (elastofilcon A) Contact LensesBausch & Lomb Incorporated

Rochester, NY

14609

Change the manufacturing process of the optical tools used to manufacture the device.
P870025/S010

10/12/11

Fetal Acoustic Stimulator (FAST)Wipro GE Healthcare

Laurel, MD

20723

Changes to the suppliers for components of the FAST device.
P890003/S236

10/21/11

ProdigyMedtronic, Inc.

Mounds View, MN

55112

Change to upgrade the software version from 1.5.1 to 1.5.2 on a laser welder at a supplier.
P910023/S274

10/7/11

Fortify ICDsSt. Jude Medical

Sylmar, CA

91392

Changes to the limits for a device level manufacturing test as well as the addition of in-process verification tests.
P910023/S275

10/12/11

Fortify ICDsSt. Jude Medical

Sylmar, CA

91392

Use of an alternate supplier for back-up bands.
P940015/S022

10/7/11

Synvisc® and Synvisc-One®Genzyme Corporation

Cambridge, MA

02142

Addition of a syringe assembly machine to the packaging department.
P940015/S023

10/7/11

Synvisc® and Synvisc-One®Genzyme Corporation

Cambridge, MA

02142

Addition of a raw material identification system and an automated filter integrity test instrument.
P950005/S035

10/7/11

Celsius, Celsius RMT, EZ Steer, EZ Steer DS, Non-Temperature Sensing Ablation Catheters and Interface CablesBiosense Webster, Inc.

Diamond Bar, CA

91765

Parametric release of sterilized product using ethylene oxide.
P960009/S127

10/21/11

Activa Family of Implantable NeurostimulatorsMedtronic, Inc.

Minneapolis, MN

55432

Implement software updates to the Self Test application of the Next Generation Tester.
P960013/S067

10/6/11

Tendril Family of LeadsSt Jude Medical, Inc.

Sylmar, CA

91342

Increase the length of the ring electrode masking.
P960040/S246

10/26/11

Cognis CRT-DsBoston Scientific Corporation

St. Paul, MN

55112

Alternate supplier of ceramic capacitor used for pulse generator (PG) manufacturing.
P960058/S092

10/26/11

Harmony HiResolution Bionic Ear SystemAdvanced Bionics Corporation

Sylmar, CA

91342

Change in the manufacturing process to improve an insertion tool and to document a change in the tool suppliers.
P970003/S136

10/18/11

VNS Therapy® Pulse GeneratorsCyberonics, Inc.

Houston, TX

77058

Change to inventory control and traceability of components and subassemblies.
P970003/S137

10/21/11

VNS Therapy® SystemCyberonics, Inc.

Houston, TX

77058

Change in the acceptance criteria for the Model 102/102R Pulse Generators.
P970003/S138

10/27/11

VNS Therapy® SystemCyberonics, Inc.

Houston, TX

77058

Implementation of Statistical Process Control (SPC) software.
P970008/S059

10/26/11

Urologix Targis System for the Treatment of BPHUrologix, Inc.

Minneapolis, MN

55447

Change in adhesive in the manufacturing of the Urologix Targis System control units.
P970020/S069

10/28/11

Multi-Link Zeta and Ultra Coronary Stent SystemsAbbott Vascular, Inc.

Temecula, CA

92591

Automated process for preparation of the adaption cup.
P970027/S016

10/19/11

AxSYM Anti HCVAbbott Laboratories

Abbott Park, IL

60064

Relocation of a formulation room for the lyophilization of alkaline-treated casein used in the device.
P980016/S322

10/13/11

EnTrust, Intrinsic, Marquis, Maximo, Maximo II, Protecta, Protecta XT,

Secura, Virtuoso, and Virtuoso II ICDs

Medtronic, Inc.

Mounds View, MN

55112

Software updates for a testing application.
P980035/S241

10/13/11

Adapta, Advisa, EnRhythm, Relia, Sensia, and Versa IPGsMedtronic, Inc.

Mounds View, MN

55112

Software updates for a testing application.
P980035/S243

10/21/11

350 Series, Adapta, EnPulse, EnRhythm, Relia, Sensia, Sigma and VersaMedtronic, Inc.

Mounds View, MN

55112

Change to upgrade the software version from 1.5.1 to 1.5.2 on a laser welder at a supplier.
P990001/S095

10/13/11

Vitatron DA+ C-Series and Vitatron DA+ T-Series IPGsMedtronic, Inc.

Mounds View, MN

55112

Software updates for a testing application.
P990001/S097

10/21/11

Vitatron DA+ C-Series IPGMedtronic, Inc.

Mounds View, MN

55112

Change to upgrade the software version from 1.5.1 to 1.5.2 on a laser welder at a supplier.
P990025/S029

10/7/11

NaviStar, NaviStar RMT, EZ Steer Nav, QwikStar Catheters and Interface CablesBiosense Webster, Inc.

Diamond Bar, CA

91765

Parametric release of sterilized product using ethylene oxide.
P990071/S015

10/7/11

Interface CablesBiosense Webster, Inc.

Diamond Bar, CA

91765

Parametric release of sterilized product using ethylene oxide.
P000010/S025

10/11/11

AMPLICOR HCV Test, v2.0Roche Molecular Systems, Inc.

Pleasanton, CA

94588

Changes to the room location and equipment for filling and labeling of certain vialed intermediate components.
P000012/S035

10/11/11

COBAS AMPLICOR HCV Test, v2.0 and COBAS AmpliPrep/ COBAS AMPLICOR HCV Test, v2.0Roche Molecular Systems, Inc.

Pleasanton, CA

94588

Changes to the room location and equipment for filling and labeling of certain vialed intermediate components.
P000039/S042

10/21/11

AMPLATZER Septal Occluder AMPLATZER 45 Delivery and Exchange SystemsAGA Medical Corporation

Plymouth, MN

55442

Change the current seal test method from manual to semiautomatic.
P000040/S019

10/3/11

HTA System ProCerva Procedure SetBoston Scientific Corporation

Marlborough, MA

01752

Addition of a new manufacturing fixture and the modifications of an existing manufacturing fixture.
P000053/S039

10/26/11

AMS 800 Urinary Control SystemAmerican Medical Systems

Minnetonka, MN

55343

Change in the packaging process for the devices.
P010012/S272

10/26/11

Teligen ICDsBoston Scientific Corporation

St. Paul, MN

55112

Alternate supplier of ceramic capacitor used for pulse generator (PG) manufacturing.
P010015/S138

10/13/11

Consulta and Syncra CRT-PsMedtronic, Inc.

Mounds View, MN

55112

Software updates for a testing application.
P010015/S140

10/21/11

InSync IIIMedtronic, Inc.

Mounds View, MN

55112

Change to upgrade the software version from 1.5.1 to 1.5.2 on a laser welder at a supplier.
P010019/S026

10/28/11

Lotrafilcon A and Lotrafilcon B Soft Contact Lenses for Extended WearCIBA VISION Corporation

Duluth, GA

30097

Addition of an alternate supplier for Isopropyl Alcohol (IPA).
P010020/S021

10/26/11

Acticon NeosphincterAmerican Medical Systems

Minnetonka, MN

55343

Change in the packaging process for the devices.
P010030/S030

10/26/11

LifeVest Wearable Cardioverter DefibrillatorZOLL Lifecor Corporation

Pittsburgh, PA

15238

Alternate supplier for the holster and a change to the incoming inspection sampling plan.
P010031/S276

10/13/11

Concerto, Concerto II, Consulta, InSync II Marquis, InSync III Marquis,

InSync Maximo, InSync Sentry, Maximo II, Protecta, and Protecta XT

ICDs

Medtronic, Inc.

Mounds View, MN

55112

Software updates for a testing application.
P010047/S013

10/19/11

ProGel™ Pleural Air Leak SealantNeomend, Inc.

Irvine, CA

92618

Reduction in sample size of the current testing for the applicator kits.
P010068/S025

10/7/11

Celsius DS, NaviStar DS, NaviStar RMT DS, EZ Steer Nav DS, QwikStar DS Catheters and Interface CablesBiosense Webster, Inc.

Diamond Bar, CA

91765

Parametric release of sterilized product using ethylene oxide.
P020004/S065

10/24/11

GORE EXCLUDER AAA EndoprosthesisW.L. Gore & Associates, Inc.

Flagstaff, AZ

86001

Change to visual inspection criteria for the stent graft deployment line fiber.
P020004/S066

10/27/11

GORE EXCLUDER AAA EndoprosthesisW.L. Gore & Associates, Inc.

Flagstaff, AZ

86001

Update in bacterial endotoxin testing software.
P020009/S078

10/19/11

Express and Express 2 Coronary Stent SystemsBoston Scientific Corporation

Maple Grove, MN

55311

Additional sterilization cycle for the device.
P020009/S079

10/31/11

Express Coronary Stent SystemBoston Scientific Corporation

Maple Grove, MN

55311

Process settings to be optimized or defined for extrusion of the proximal outer component.
P020024/S034

10/21/11

AMAPLATZER Duct Occluder 180 Delivery and Exchange SystemAGA Medical Corporation

Plymouth, MN

55442

Change the current seal test method from manual to semiautomatic.
P020045/S040

10/7/11

Freezor Cardiac CryoAblation Catheter, Freezor Xtra Surgical and Freezor MAX Surgical CryoAblation DevicesMedtronic CryoCath LP

Pointe Claire, Quebec

H9R5Z8

Change to reduce adhesive curing time for ECG rings and the tip electrode.
P020047/S040

10/28/11

Multi-Link Vision, Multi-Link Mini Vision, ML8 Coronary Stent SystemsAbbott Vascular, Inc.

Temecula, CA

92591

Automated process for preparation of the adaption cup.
P020052/S008

10/13/11

Response™ CV Cardioversion Electrophysiology Catheter and System Accessory EquipmentSt. Jude Medical, Inc.

Minnetonka, MN

55345

Eliminate the UV Post Trim process.
P030009/S060

10/19/11

Driver OTW Stent SystemMedtronic, Inc.

Santa Rosa, CA

95403

Changing the product print information from a manual process to an automated process.
P030017/S123

10/12/11

Precision® Spinal Cord Stimulator SystemBoston Scientific Neuromodulation

Valencia, CA

91355

Add an alternative welder for the antenna welding process.
P030031/S035

10/7/11

Celsius ThermoCool, Celsius RMT ThermoCool, NaviStar ThermoCool, NaviStar RMT ThermoCool, EZ Steer ThermoCool and EZ Steer ThermoCool Nav CathetersBiosense Webster, Inc.

Diamond Bar, CA

91765

Parametric release of sterilized product using ethylene oxide.
P030032/S013

10/7/11

PREVELLE SilkGenzyme Corporation

Cambridge, MA

02142

Addition of a raw material identification system and an automated filter integrity test instrument.
P030054/S201

10/7/11

Unify CRT-DsSt. Jude Medical

Sylmar, CA

91392

Changes to the limits for a device level manufacturing test as well as the addition of in-process verification tests.
P030054/S203

10/12/11

Unify CRT-DsSt. Jude Medical

Sylmar, CA

91392

Use of an alternate supplier for back-up bands.
P040016/S078

10/14/11

VeriFLEX (Liberté) Coronary Stent SystemBoston Scientific Corporation

Maple Grove, MN

55311

Implementation of a semi-automated kitting process of accessory kits at a contract supplier.
P040016/S079

10/19/11

VeriFLEX OTW Bare Metal Coronary Stent SystemBoston Scientific Corporation

Maple Grove, MN

55311

Updates to the Hydrophilic Coating (HPC) equipment process.
P040016/S080

10/31/11

VeriFLEX Coronary Stent System (Formerly Liberté)Boston Scientific Corporation

Maple Grove, MN

55311

Process settings to be optimized or defined for extrusion of the proximal outer component.
P040016/S081

10/31/11

VeriFLEX (Liberté) Bare Metal Coronary Stent SystemBoston Scientific Corporation

Maple Grove, MN

55311

Hardware and software updates for the Plasma Treater.
P040020/S038

10/6/11

AcrySof Intraocular Lenses (IOLs)Alcon Research, Ltd.

Fort Worth, TX

76134

Modifications to the final cleaning process.
P040027/S025

10/27/11

GORE VIATORR TIPS EndoprosthesisW.L. Gore & Associates, Inc.

Flagstaff, AZ

86001

Final product assembly at the firm’s Phoenix location.
P040027/S026

10/27/11

GORE VIATORR TIPS EndoprosthesisW.L. Gore & Associates, Inc.

Flagstaff, AZ

86001

Update in bacterial endotoxin testing software.
P040036/S026

10/7/11

NaviStar ThermoCool, NaviStar RMT ThermoCool, EZ Steer ThermoCool and EZ Steer ThermoCool Nav CathetersBiosense Webster, Inc.

Diamond Bar, CA

91765

Parametric release of sterilized product using ethylene oxide.
P040037/S038

10/27/11

GORE VIABAHN EndoprosthesisW.L. Gore & Associates, Inc.

Flagstaff, AZ

86001

Update in bacterial endotoxin testing software.
P040040/S019

10/21/11

AMPLATZER Muscular VSD OccluderAGA Medical Corporation

Plymouth, MN

55442

Change the current seal test method from manual to semiautomatic.
P040043/S042

10/24/11

GORE TAG Thoracic EndoprosthesisW.L. Gore & Associates, Inc.

Flagstaff, AZ

86001

Change to visual inspection criteria for the stent graft deployment line fiber.
P040043/S043

10/27/11

GORE TAG THORACIC EndoprosthesisW.L. Gore & Associates, Inc.

Flagstaff, AZ

86001

Update in bacterial endotoxin testing software.
P040045/S025

10/12/11

VISTAKON (senofilcon A) Brand Contact LensesJohnson & Johnson Vision Care, Inc.

Jacksonville, FL

32256

Upgrade to the saline dose head during the manufacturing of the device.
P040045/S027

10/26/11

Vistakon (senofilcon A) Contact Lenses, Clear & Visibly Tinted with UV BlockerJohnson & Johnson Vision Care, Inc.

Jacksonville, FL

32256

Update the current test method for Vistakon (senofilcon A) Contact Lenses.
P050006/S021

10/21/11

GORE HELEX Septal OccluderW.L. Gore & Associates, Inc.

Flagstaff, AZ

86001

Replacement of sand paper with a lock loop polishing tool in the manufacture of the subject device.
P050006/S022

10/27/11

GORE HELEX Septal OccluderW.L. Gore & Associates, Inc.

Flagstaff, AZ

86001

Addition of a procedure for inventory processing.
P050006/S023

10/19/11

GORE HELEX Septal OccluderW.L. Gore & Associates, Inc.

Flagstaff, AX

86001

Addition of Expiry Report requirement to the return product procedure.
P050006/S024

10/27/11

GORE HELEX Septal OccluderW.L. Gore & Associates, Inc.

Flagstaff, AZ

86001

Update in bacterial endotoxin testing software.
P050006/S026

10/28/11

GORE HELEX Septal OccluderW.L. Gore & Associates, Inc.

Flagstaff, AZ

86001

Adoption of an instruction for single piece flow in the boxing operation.
P050018/S015

10/27/11

AngioSculpt PTCA Scoring Balloon CatheterAngioscore, Inc.

Fremont, CA

94538

Remove redundant in-process inspection tests.
P050028/S022

10/11/11

COBAS TaqMan HBV Test For Use with The High Pure System and COBAS AmpliPrep/COBAS TaqMan HBV Test v2.0Roche Molecular Systems, Inc.

Pleasanton, CA

94588

Changes to the room location and equipment for filling and labeling of certain vialed intermediate components.
P060002/S021

10/31/11

Bard Flair Endovascular Stent GraftC.R. Bard, Inc.

Tempe, AZ

85281

Introduction of an automated labeling inspection system and introduction of a new barcode scan system.
P060003/S010

10/3/11

Abbott AxSYM AUSABAbbott Laboratories Abbott Park, IL

60064

Change to vendor for the incoming Non-Fat Dry Milk.
P060008/S077

10/14/11

TAXUS Liberté Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation

Maple Grove, MN

55311

Implementation of a semi-automated kitting process of accessory kits at a contract supplier.
P060008/S078

10/14/11

TAXUS Liberté Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation

Maple Grove, MN

55311

Change to the feedstock source for the manufacturing of a solvent.
P060008/S079

10/19/11

TAXUS Liberté OTW Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation

Maple Grove, MN

55311

Updates to the Hydrophilic Coating (HPC) equipment process.
P060008/S080

10/31/11

TAXUS Liberté Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation

Maple Grove, MN

55311

Process settings to be optimized or defined for extrusion of the proximal outer component.
P060008/S081

10/31/11

TAXUS Liberté Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation

Maple Grove, MN

55311

Hardware and software updates for the Plasma Treater.
P060022/S009

10/7/11

Akreos Posterior Chamber Intraocular LensesBausch & Lomb, Inc.

Aliso Viejo, CA

92656

Transfer of bioburden testing of the Akreos Adapt AO Holder Folder, M160 Holder, and Parker Gasket from a contract vendor to Bausch & Lomb.
P060030/S023

10/11/11

COBAS AmpliPrep/ COBAS TaqMan HCV TestRoche Molecular Systems, Inc.

Pleasanton, CA

94588

Changes to the room location and equipment for filling and labeling of certain vialed intermediate components.
P060033/S068

10/19/11

Endeavor Sprint Zotarolimus-Eluting Coronary Stent SystemMedtronic, Inc.

Santa Rosa, CA

95403

Changing the product print information from a manual process to an automated process.
P070007/S032

10/19/11

Talent Thoracic Stent Graft with Xcelerant Delivery SystemMedtronic Vascular

Santa Rosa, CA

95403

Modification of a wiping procedure.
P070014/S024

10/7/11

LifeStent Vascular Stent SystemsBard Peripheral Vascular, Inc.

Tempe, AZ

85281

Change to the tensile testing process.
P070014/S028

10/31/11

LifeStent Vascular StentC.R. Bard, Inc.

Tempe, AZ

85281

Introduction of an automated labeling inspection system and introduction of a new barcode scan system.
P070015/S081

10/28/11

XIENCE V and PROMUS Everolimus-Eluting Coronary StentAbbott Vascular, Inc.

Temecula, CA

92591

Automated process for preparation of the adaption cup.
P070027/S033

10/19/11

Abdominal Stent Graft with the Xcelerent System, Talent Converter Stent Graft with the Xcelerant SystemMedtronic Vascular

Santa Rosa, CA

95403

Modification of a wiping procedure.
P080004/S009

10/26/11

Hoya iSphericHoya Surgical Optics, Inc.

Chino Hills, CA

91709

Change to the endotoxin testing method.
P080007/S008

10/31/11

E-LUMINEXX Vascular Stent GraftC.R. Bard, Inc.

Tempe, AZ

85281

Introduction of an automated labeling inspection system and introduction of a new barcode scan system.
P090013/S039

10/13/11

Revo MRI IPGMedtronic, Inc.

Mounds View, MN

55112

Software updates for a testing application.
P090028/S001

10/21/11

VITROS Immunodiagnostic Products HBeAg Reagent Pack and VITROS Immunodiagnostic Products HBeAg CalibratorOrtho-Clinical Diagnostics, Inc.

Rochester, NY

14626

Conversion of the in-process limit for the process control of the selling calibrator from a signal ratio to a numerical test result.
P100010/S012

10/7/11

Freezor MAX Cardiac CryoAblation CatheterMedtronic CryoCath LP

Pointe Claire, Quebec

H9R5Z8

Change to reduce adhesive curing time for ECG rings and the tip electrode.
P100023/S020

10/6/11

ION (TAXUS Element) Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation

Maple Grove, MN

55311

Addition of the ION Stent System to sterilization Chamber 6 at Coventry, Rhode Island.
P100023/S021

10/14/11

ION Paclitaxel-Eluting Platinum Chromium Coronary Stent SystemBoston Scientific Corporation

Maple Grove, MN

55311

Change to the feedstock source for the manufacturing of a solvent.
P100023/S022

10/19/11

ION (TAXUS Element) Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation

Maple Grove, MN

55311

Updates to the Hydrophilic Coating (HPC) equipment process.
P100023/S023

10/27/11

ION (Taxus Element) Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation

Maple Grove, MN

55311

Change to the in-process monitoring plan for proximal and port welds.
P100023/S024

10/19/11

ION (TAXUS Element) Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation

Maple Grove, MN

55311

Updates to the Marker Band and DVT equipment inspection software.
P100023/S025

10/28/11

ION (Taxus Element) Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation

Maple Grove, MN

55311

Modification to the sampling plan for the laser cutting set up.
P100023/S026

10/31/11

ION (TAXUS Element) Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation

Maple Grove, MN

55311

Hardware and software updates for the Plasma Treater.
P100029/S009

10/19/11

Trifecta ValveSt. Jude Medical, Inc.

St. Paul, MN

55117

Change to the in-process limit for total valve score during the visual inspection and functional test.
P110020/S001

10/17/11

cobas® 4800 BRAF V600 mutation testRoche Molecular Systems, Inc.

Pleasanton, CA

94588

Addition of functional testing at the final vial stage in the manufacture of the device mutation positive control (MU) and the wild-type control (WT).
P110020/S002

10/26/11

cobas® 4800 BRAF V600 mutation testRoche Molecular Systems, Inc.

Pleasanton, CA

94588

Changes to the filling and labeling equipment and location for certain vialed intermediate components. The firm has proposed relocation to Building 502 Rooms 1F24 and 1F26 from Building 502 Rooms 1F23 and 1F31 for use of new equipment Kugler Linoline 120 Filing and Screw-capping Line which includes the Accraply 4000 and 35T Labeling Machines.

Summary of PMA Originals & Supplements Approved

Originals: 4

Supplements: 52

Summary of PMA Originals Under Review

Total Under Review: 88

Total Active: 41

Total On Hold: 47

Number Greater Than 180 Days: 3

Summary of PMA Supplements Under Review

Total Under Review: 554

Total Active: 437

Total On Hold: 117

Number Greater Than 180 Days: 11

Summary of All PMA Submissions Received

Originals: 2

Supplements: 66

Summary of PMA Supplement PMA Approval/Denial Decision Times

Number of Approvals: 52

Number of Denials: 0

Average Days Fr Receipt to Decision (Total Time): 210.9

FDA Time: 127.9 Days MFR Time: 83 Days

SOURCE

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