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PMA Final Decisions for April 2011

Mon, 06/06/2011 - 10:31am
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
N17679/S035

4/29/11

Tetrafilcon ACooper Vision, Inc. Pleasanton, CA 94588Changes in criteria for acceptance for water content from 5% to 2%, and revision to maximum specifications of lens material components and the specification for water content.
N18033/S054

4/7/11

VISTAKON (etafilcon A) Contact Lenses, Clear and Visibly Tinted with UV BlockerJohnson & Johnson Vision Care, Inc.

Jacksonville, FL 32256

Change in the sampling frequency of an in-process quality audit.
P810002/S073

4/8/11

St. Jude Mechanical Heart ValvesSt. Jude Medical

St. Paul, MN

55117

Revised steam sterilization load configuration.
P830037/S052

4/21/11

FreshLook (phemfilcon A) Soft Contact Lenses for Extended WearCIBA VISION Corporation

Duluth, GA

30097

Upgrading the control system in the Finn Aqua Sterilizer FA5.
P830060/S068

4/29/11

VENTAK Family of ICDsBoston Scientific Corporation

St. Paul, MN

55112

Change in biological indicator model used as part of the manufacturing process.
P840068/S049

4/29/11

DELTA and VISTA Families of PacemakersBoston Scientific Corporation

St. Paul, MN

55112

Change in biological indicator model used as part of the manufacturing process.
P890003/S217

4/6/11

CareLink Remote Home Monitor and CardioSight ReaderMedtronic, Inc.

Mounds View, MN

55112

The transfer of final device packaging inspection activities.
P890061/S019

4/29/11

VENTAK P Family of ICDsBoston Scientific Corporation

St. Paul, MN

55112

Change in biological indicator model used as part of the manufacturing process.
P910073/S095

4/29/11

ENDOTAK RELIANCE LeadsBoston Scientific Corporation –CRM St. Paul, MN

55112

Make BSC the primary supplier of the 4-SITE lead terminal assembly.
P910073/S096

4/29/11

ENDOTAK Family of LeadsBoston Scientific Corporation

St. Paul, MN

55112

Change in biological indicator model used as part of the manufacturing process.
P910077/S112

4/29/11

Latitude™ CommunicatorBoston Scientific Corporation

St. Paul, MN

55112

Rework of Printed Circuit Assemblies (PCAs) used in the manufacture of the Latitude™ Communicator.
P910077/S113

4/29/11

VENTAK PRx/MINI Families of ICDsBoston Scientific Corporation

St. Paul, MN

55112

Change in biological indicator model used as part of the manufacturing process.
P930035/S020

4/29/11

VENTAK P2 Family of ICDsBoston Scientific Corporation

St. Paul, MN

55112

Change in biological indicator model used as part of the manufacturing process.
P930038/S066

4/8/11

Angio-Seal Vascular Closure DeviceSt. Jude Medical

St. Paul, MN

55117

Elimination of a component cleaning.
P940008/S027

4/29/11

RES-Q and RES-Q MICRON Families of LeadsBoston Scientific Corporation

St. Paul, MN

55112

Change in biological indicator model used as part of the manufacturing process.
P940031/S071

4/29/11

VIGOR DR/SR, DISCOVERY, and MERIDIAN Families of PacemakersBoston Scientific Corporation

St. Paul, MN

55112

Change in biological indicator model used as part of the manufacturing process.
P950001/S022

4/29/11

SELUTE Lead FamilyBoston Scientific Corporation

St. Paul, MN

55112

Change in biological indicator model used as part of the manufacturing process.
P950005/S034

4/6/11

Celsius, RMT, EZ Steer, EZ Steer DS Non-Temperature Sensing Ablation CathetersBiosense Webster, Inc.

Diamond Bar, CA

91765

Addition of a second qualified chamber for the sterilization process.
P950029/S058

4/8/11

REPLY SR/DR and ESPRIT SR/DR Implantable Cardiac PacemakersSorin CRM, Inc.

Plymouth, MN

55441

Update to the electronic hybrid module cleaning process.
P950037/S094

4/6/11

Evia DR, DR-T, SR and SR-T, Entovis DR, DR-T, SR and SR-T, Estella DR, DR-T, SR and SR-T, Ecuro DR, DR-T, SR and SR-T and Effecta D, DR, S and SRBiotronik, Inc.

Lake Oswego, OR

97035

New supplier site for the manufacture of electrical modules.
P960004/S049

4/29/11

THINLINE/

FINELINE Families of Leads

Boston Scientific Corporation

St. Paul, MN

55112

Change in biological indicator model used as part of the manufacturing process.
P960006/S030

4/29/11

SWEET TIP Rx, SWEET PICOTIP Rx, and FLEXTEND Families of LeadsBoston Scientific Corporation

St. Paul, MN

55112

Change in biological indicator model used as part of the manufacturing process.
P960009/S113

4/29/11

Activa® Implantable NeurostimulatorsMedtronic Neuromodulation

Minneapolis, MN 55432

Implementation of manufacturing changes for Activa® devices.
P960011/S019

4/1/11

BV1% OVD (1% sodium hyaluronate viscoelastic surgical aid fluid)Ferring Pharmaceuticals, Inc.

Parsippany, NJ

07054

Alternate rheometer for testing in-process control and finished product samples.
P960013/S064

4/6/11

1782 Tendril LeadsSt. Jude Medical, Inc.

Sylmar, CA

91342

Addition of an alternate supplier for the connector ring crimp core.
P960040/S243

4/29/11

VENTAK AV, VENTAK PRIZM DR/VR, VITALITY, CONFIENT and LIVIAN Families of ICDsBoston Scientific Corporation

St. Paul, MN

55112

Change in biological indicator model used as part of the manufacturing process.
P970003/S125

4/29/11

VNS Therapy® SystemCyberonics, Inc. Houston, TX

77058

Modification of visual inspection acceptance criteria for three capacitors.
D970003/S127

4/29/11

Pulsar, Pulsar Max, Insignia, and Altrua Families of PacemakersBoston Scientific Corporation

St. Paul, MN

55112

Change in biological indicator model used as part of the manufacturing process.
P970008/S056

4/29/11

Urologix Targis System for the Treatment of BPHUrologix, Inc.

Minneapolis, MN 55447

Changes in the quality control testing.
P970020/S062

4/8/11

MULTI-LINK ZETA® Coronary Stent SystemAbbott Vascular, Inc.

Temecula, CA

92591

Change in extruded tubing length, and a change from a manual tube cutting process to an automated process.
P970021/S034

4/5/11

GYNECARE THERMACHOICE III Uterine Balloon Therapy SystemETHICON, Women’s Health and Urology

Somerville, NJ

08876

Manufacturing location change of a raw material supplier.
P970037/S005

4/8/11

AutoDELFIA® hAFPPerkinElmer, Inc.

Indianapolis, IN 46236

Change in a raw material used in the manufacture of the Enhancement Solution auxiliary reagent used with the AutoDELFIA hAFP kit.
P980035/S208

4/4/11

Adapta, Versa, Sensia, Relia IPGsMedtronic, Inc.

Mounds View, MN 55112

Upgrades to test system hardware and software.
P990025/S028

4/6/11

NaviStar, RMT, EZ Steer Nav, Qwikstar Interface CablesBiosense Webster, Inc.

Diamond Bar, CA

91765

Addition of a second qualified chamber for the sterilization process.
P990071/S012

4/6/11

Interface CablesBiosense Webster, Inc.

Diamond Bar, CA

91765

Addition of a second qualified chamber for the sterilization process.
P000039/S041

4/8/11

AMPLATZER® Septal OccluderAGA Medical Corporation

Plymouth, MN

55442

Modifications to pouch sealing equipment.
P010012/S266

4/29/11

CONTAK CD, LIVIAN, and COGNIS Families of CRT-Ds and EASYTRAK and ACUITY SPIRAL Families of LeadsBoston Scientific Corporation

St. Paul, MN

55112

Change in biological indicator model used as part of the manufacturing process.
P010013/S034

4/8/11

NovaSure Impedance Controlled Endometrial Ablation SystemHologic, Inc.

Marlborough, MA

01752

Implementation of a microbiology laboratory.
P010029/S012

4/1/11

EUFLEXXA®

(1% Sodium Hyaluronate)

Ferring Pharmaceuticals, Inc.

Parsippany, NJ

07054

Alternate rheometer for testing in-process control and finished product samples.
P010068/S024

4/6/11

EZ Steer Nav DS and Qwikstar DS CathetersBiosense Webster, Inc.

Diamond Bar, CA

91765

Addition of a second qualified chamber for the sterilization process.
P020004/S061

4/8/11

GORE EXCLUDER® AAA EndoprosthesisW.L. Gore & Associates

Flagstaff, AZ

86001

Automation of the trimming process during the trunk wrapping and forming step.
P020024/S033

4/8/11

AMPLATZER® Duct OccluderAGA Medical Corporation

Plymouth, MN

55442

Modifications to pouch sealing equipment.
P020045/S036

4/29/11

Universal CryoConsoleMedtronic, Inc. Mounds View, MN 55112Addition of an additional calibration, calibration equipment, and associated documentation change.
P020045/S038

4/29/11

Freezor, Freezor Xtra, Freezor Max Cryoablation CathetersMedtronic CryoCath LP

Pointe Claire, Quebec, Canada

Transfer the gas filling and testing operations for the compressor subassembly to the supplier.
P020047/S033

4/8/11

MULTI-LINK VISION® and MULTI-LINK MINI-VISION® OTW and RX Coronary Stent SystemsAbbott Vascular, Inc.

Temecula, CA

92591

Change in extruded tubing length, and a change from a manual tube cutting process to an automated process.
P030005/S074

4/29/11

CONTAK RENEWAL TR Family of CRT-PsBoston Scientific Corporation

St. Paul, MN

55112

Change in biological indicator model used as part of the manufacturing process.
P030026/S021

4/22/11

VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and CalibratorOrtho Clinical Diagnostics, Inc. Rochester, NY

14626

Change in the manufacturing scale of a reagent component.
P030031/S032

4/6/11

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

Diamond Bar, CA

91765

Addition of a second qualified chamber for the sterilization process.
P030052/S005

4/8/11

UroVysion Bladder Cancer KitAbbott Molecular, Inc.

Des Plaines, IL

60018

Changes to the reference DNA manufacturing and the small scale fermentation processes.
P040036/S023

4/6/11

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

Diamond Bar, CA

91765

Addition of a second qualified chamber for the sterilization process.
P040040/S018

4/8/11

AMPLATZER® Muscular VSD OccluderAGA Medical Corporation

Plymouth, MN

55442

Modifications to pouch sealing equipment.
P050018/S013

4/8/11

AngioSculpt® PTCA Scoring Balloon Catheter, Easy ExchangeAngioscore, Inc.

Fremont, CA

94538

Addition of an inflation lumen inspection.
P050046/S010

4/29/11

ACUITY Steerable LeadsBoston Scientific Corporation

St. Paul, MN

55112

Change in biological indicator model used as part of the manufacturing process.
P060007/S012

4/21/11

ARCHITECT HBsAg and ARCHITECT HBsAg Confirmatory AssaysAbbott Laboratories

Abbott Park, IL

60064

Test method conversions, raw material and vendor changes.
P060009/S005

4/4/11

AxSYM CORE-M 2.0Abbott Laboratories Abbott Park, IL 60064Changes to replace reagents for in- process testing of the HBV core antigen (anti-HBc) specific activity and to allow the use of two alternative precursors for manufacturing of the Purified Filtered HBc IgG within the Abbott Park, Illinois manufacturing facility.
P060031/S005

4/28/11

Bio-Rad MONOLISA™ Anti-HBc EIABio-Rad Laboratories, Inc.

Redmond, WA 98052

Change in the scale of manufacture of the Conjugate reagent component of the Bio-Rad MONOLISA™ Anti-HBc EIA.
P070015/S061

4/8/11

XIENCE V® and PROMUS Everolimus Eluting Coronary Stent SystemAbbott Vascular, Inc.

Temecula, CA

92591

Change in extruded tubing length, and a change from a manual tube cutting process to an automated process.
P070015/S062

4/8/11

XIENCE V® and PROMUS™ Everolimus Eluting Coronary Stent SystemsAbbott Vascular

Temecula, CA

92591

Remove redundant cleaning and treatment steps.
P070015/S063

4/8/11

XIENCE V® and PROMUS™ Everolimus Eluting Coronary Stent SystemsAbbott Vascular

Temecula, CA

92591

Modification of cleanroom classification and gowning requirements.
P070015/S065

4/29/11

XIENCE® and PROMUS Everolimus Eluting Coronary Stent SystemAbbott Vascular

Temecula, CA 92591

Extension of shelf life and retest date of an intermediate component.
P070015/S066

4/29/11

XIENCE V® Eluting Coronary Stent System and PROMUS™ Everolimus Eluting Coronary Stent SystemAbbott Vascular Temecula, CA

92591

Modification of a sampling plan for particulate testing.
P070022/S016

4/14/11

Adiana Permanent Contraception SystemHologic, Inc.

Marlborough, MA 01752

Change in inspection procedure.
P070022/S017

4/8/11

Adiana Permanent Contraception SystemHologic, Inc.

Marlborough, MA

01752

Implementation of a microbiology laboratory.
P080004/S006

4/7/11

Hoya iSpheric Intraocular LensHoya Surgical Optics, Inc.

Chino Hills, CA

91709

Changes to the previously approved test laboratory and to the LAL test method.
P100010/S009

4/29/11

Balloon CatheterMedtronic CryoCath LP

Pointe Claire, Quebec, Canada

Transfer the gas filling and testing operations for the compressor subassembly to the supplier.

Summary of PMA Originals & Supplements Approved

Originals: 6

Supplements: 85

Summary of PMA Originals Under Review

Total Under Review: 100

Total Active: 49

Total On Hold: 51

Number Greater Than 180 Days: 4

Summary of PMA Supplements Under Review

Total Under Review: 725

Total Active: 539

Total On Hold: 186

Number Greater Than 180 Days: 11

Summary of All PMA Submissions Received

Originals: 10

Supplements: 55

Summary of PMA Supplement PMA Approval/Denial Decision Times

Number of Approvals: 85

Number of Denials: 0

Average Days Fr Receipt to Decision (Total Time): 175.8

FDA Time: 104.2 Days MFR Time: 71.6 Days

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