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PMA Final Decisions for September 2010(2)

Tue, 10/19/2010 - 12:31pm
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.

None.

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P840068/S047

9/14/10

Real-Time

DELTA Pacemaker System Boston Scientific Corporation

St. Paul, MN

55112

Approval for changes to the Model 3120 Programmer System Software Model 2909 from Version 6.01 to version 7.01.
P870078/S008

9/20/10

180-Day

Hancock® Apical Left Ventricle Connector Medtronic Heart Valves

Santa Ana, CA

92705

Approval for the Hancock® Apical Left Ventricle Connector, Model 174A. The device is indicated for providing an alternative method for relief of left ventricular

hypertension in patients with severe left ventricular outflow tract obstruction due to hypoplasia of

the aortic root, hypoplasia of the aortic annulus, or acquired problems secondary to aortic valve replacement which cannot be relieved through conventional techniques.

P880091/S032

9/16/10

Special

Silicon UV-Absorbing Posterior Chamber Intraocular Lens (IOL) STAAR Surgical Company

Monrovia, CA

91016

Approval for a modification to the Directions for Use to comply with the latest Medical Device Directive (MDD) 93/42/EEC.
P900056/S098

9/23/10

135-Day

Rotablator™ Rotational Angioplasty System Boston Scientific Corporation

Cardiovascular

Maple Grove, MN

55311

Approval for a manufacturing production area move of the manufacture and service of the device Console and Dynaglide™ Foot Pedal assemblies.
P910023/S239

9/23/10

Real-Time

Fortify VR/DR St. Jude Medical

Cardiac Rhythm Management Division

Sunnyvale, CA

94086

Approval for changes to the labeling to include longevity information based on additional bench testing.
P910023/S243

9/9/10

180-Day

Programmer Support for Atlas II+ HF and Promote St. Jude Medical

Sylmar, CA

91342

Approval of the post-approval study protocol.
P910023/S246

9/23/10

Real-Time

Epic, Epic+, Epic II, Atlas, Atlas+, Atlas II, Current, Current+, Fortify VR/DR St. Jude Medical Cardiac Rhythm Management

Sunnyvale, CA

94086

Approval for modifications to the connector blocks including the use of metal injection molding (MIM) and the use of MP35N as the material.
P910073/S084

9/28/10

135-Day

Reliance Family of Leads Boston Scientific Cardiology, Rhythm and Vascular

St. Paul, MN

55112

Modifications to inspection criteria for a specific lead component.
P910077/S108

9/14/10

Real-Time

VENTAX PRx AICD System Boston Scientific Corporation

St. Paul, MN

55112

Approval for changes to the Model 3120 Programmer System Software Model 2909 from Version 6.01 to version 7.01.
P920023/S028

9/23/10

Real-Time

UroLume® Endoprosthesis American Medical Systems

Minnetonka, MN

55343

Approval for a modification of specifications of the radius and location of the bump on the end of the UroLume Endoprosthesis Outer Tube.
P940015/S019

9/15/10

135-Day

Synvisc/Synvisc-One Genzyme Biosurgery

Cambridge, MA

02142

Approval for a manufacturing change involving installation of the Waters Empower 2 Chromatography Data System.
P940031/S069

9/14/10

Real-Time

VIGOR DR/SR Pacemaker System Boston Scientific Corporation

St. Paul, MN

55112

Approval for changes to the Model 3120 Programmer System Software Model 2909 from Version 6.01 to version 7.01.
P950009/S012

9/16/10

Special

BD FocalPoint GS Imaging System Tripath Imaging, Inc.

Durham, NC

27703

Approval for labeling revisions regarding workload calculation.
P950022/S073

9/9/10

180-Day

Riata ST Optim and Riata STS Optim Leads St. Jude Medical

Sylmar, CA

91342

Approval of the post-approval study protocol.
P950037/S079

9/2/10

180-Day

Reliaty/Model 3145 Pacing System Analyzer Biotronik, Inc.

Lake Oswego, OR

97035

Approval for a stand-alone version of the pacing system analyzer function found in the ICS 3000 Implant Control System. The device, as modified, will be marketed under the trade name Reliaty by Biotronik, Inc. and Model 3145 by Boston Scientific and is indicated for use in pacing lead system analysis during the implantation of pacemakers and defibrillators.
P960040/S218

9/7/10

135-Day

Teligen Family of ICDs Boston Scientific Corporation

St. Paul, MN

55112

Approval for modifications to the cleaning process and moving a weld process from a supplier to Boston Scientific Corporation.
P960040/S234

9/14/10

Real-Time

VENTAX AVAICD System Boston Scientific Corporation

St. Paul, MN

55112

Approval for changes to the Model 3120 Programmer System Software Model 2909 from Version 6.01 to version 7.01.
P960058/S076

9/10/10

180-Day

Harmany HiResolution Bionic Ear System Advanced Bionics, LLC

Sylmar, CA

91342

Approval for the Off-The-EAR-Power (EOP) Accessories Designed to be used with the Behind-The-Ear (BTE) external sound processors Auria® or Harmony™.
P970003/S112

9/17/10

Real-Time

VNS Therapy System Cyberonics, Inc.

Houston, TX

77058

Approval for upgrading the operating system of the Dell X5 handheld computer.
D970003/S124

9/14/10

Real-Time

PULSAR, PULSAR MAX Pacemaker System Boston Scientific Corporation

St. Paul, MN

55112

Approval for changes to the Model 3120 Programmer System Software Model 2909 from Version 6.01 to version 7.01.
P980016/S252

9/29/10

Real-Time

Concerto,

Concerto II, Consulta,

Maximo II, Virtuoso, Secura and Virtuoso II

Medtronic, Inc.

Mounds View, MN

55112

Approval for the design changes to NPO-0402 Multilayer Ceramic Capacitors (XC269 and XC313).
P980023/S038

9/17/10

180-Day

Linox Smart Steroid-Eluting Dual Coil ICD Leads Biotronik, Inc.

Lake Oswego, OR

97035

 

Approval for Linox Smart Steroid-Eluting Dual Coil ICD Leads with Silglide Coating.
P980049/S059

9/9/10

180-Day

Paradym DR and Paradym VR ELA Medical, Inc.

Plymouth, MN

55441

Approval for revised embedded implant software (version W2.8.4) and revised Smartview programmer softwear (version 2.22 UG2).
P980049/S060

9/8/10

Real-Time

Paradym VR/DR and CRT-D ELA Medical, Inc. / Sorin Group

Plymouth, MN

55441

Approval for the design changes for low voltage electronic hybrid module and interconnection flex circuit for Paradym VR/DR and CRT-D, Models 8250, 8550, and 8750.
P990013/S029

9/16/10

Special

Collamer UV-Absorbing Posterior Chamber Intraocular Lens (IOL) STAAR Surgical Company

Monrovia, CA

91016

Approval for modification to the Directions for use to comply with the latest Medical Device Directive (MDD) 93/42/EEC.
P990037/S031

9/15/10

180-Day

Vascular Solutions Diagnostic Duett Pro Sealing Device Vascular Solutions, Inc.

Minneapolis, MN

55369

Approval for a manufacturing site located at Steris Isomedix Services, Inc., Minneapolis, Minnesota to perform the ethylene oxide pre-treatment step of the bulk collagen component of the subject device.
P990040/S012

9/27/10

Real-Time

TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System Codman & Shurtleff, Inc.

Raynham, MA

02767

Approval for relabeling and repackaging the ethiodized oil component to meet the current Codman specification.
P000021/S017

9/2/10

Real-Time

Dimension® TPSA Flex® Reagent Cartridge Siemens Healthcare Diagnostic, Inc.

Newark, DE

19714

Approval for the addition of a clot check device to the Dimension® EXL™ with LM system when used with the Dimension® TPSA Flex® Reagent Cartridge.
P000025/S046

9/3/10

135-Day

COMBI 40+ Cochlear Implant System MED-EL Corporation

Durham, NC

27713

Approval for a change in MED-EL’s supplier of a critical component.
P000025/S047

9/3/10

135-Day

COMBI 40+ Cochlear Implant System MED-EL Corporation

Durham, NC

27713

Approval for a change in the production of the thermoforming foil used to produce the blisters of the sterile package for the cochlear implants.
P000029/S066

9/3/10

135-Day

Deflux® Injectable Gel Oceana Therapeutics, Inc.

Edison, NJ

08817

Approval for changes to the sampling for testing endotoxins and bioburden and changes to the manufacturing process.
P000032/S032

9/2/10

135-Day

Her Option® Office Cryoablation Therapy System Cooper Surgical, Inc.

Trumbull, CT

06611

Approval for a change to the console testing method.
P000032/S033

9/22/10

135-Day

Her Option® Office Cryoablation Therapy System Cooper Surgical, Inc.

Trumbull, CT

06611

Approval for a change to the incoming measurement method.
P000037/S019

9/23/10

180-Day

On-X Prosthetic Heart Valve On-X Life Technologies, Inc.

Austin, TX

78754

Approval for a manufacturing site located in Austin, Texas.
P010001/S006

9/15/10

135-Day

Transcend Hip Articulation System CeramTec AG

Memphis, TN

38119

Approval for the addition of a second identical line of grinding, polishing, and cleaning processes at the Plochingen, Germany facility.
P010001/S007

9/15/10

135-Day

Transcend Hip Articulation System CeramTec AG

Memphis, TN

38119

Approval for the replacement of two grinding machines and addition of one piece of proof testing equipment at the Plochingen, Germany facility and addition of a grinding machine and piece of proof testing equipment at the Marktredwitz, Germany facility.
P010012/S230

9/16/10

Panel

Cognis CRT-D, Livian CRT-D and Contak Renewal 3 RF HE CRT-D Boston Scientific Corporation

St. Paul, MN

55112

Approval for a modification to the indications for use for the Cognis CRT-D Models N118, N119; Livian

CRT-D Models H220, H225, H227 and H229; and Contak Renewal 3 RF HE CRT-D Models

H210, H215, H217, H219 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) as follows:

These Boston Scientific Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications:

1) Moderate to severe heart failure (NYHA Class III-IV) with EF ≤ 35% and QRS duration

≥ 120 ms; or

2) Left bundle branch block (LBBB) with QRS ≥ 130 ms, EF ≤ 30%, and mild (NYHA

Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I)

ischemic heart failure.

P010012/S237

9/7/10

135-Day

Cognis Family of CRT-Ds Boston Scientific Corporation

St. Paul, MN

55112

Approval for modifications to the cleaning process and moving a weld process from a supplier to Boston Scientific Corporation.
P010012/S254

9/14/10

Real-Time

CONTAK CD/EASYTRAK CRT-D System Boston Scientific Corporation

St. Paul, MN

55112

Approval for changes to the Model 3120 Programmer System Software Model 2909 from Version 6.01 to version 7.01.
P010023/S003

9/30/10

135-Day

MAXUM System Semi-Implantable Middle Ear Hearing Device Ototronix LLC

Houston, TX

77386

Approval for a change in the Magnet Canister

Manufacturing process/inspection, and the re-qualification of the magnetization vendor at the vendor’s new facility location.

P010023/S005

9/10/10

180-Day

MAXUM System Semi-Implantable Middle Ear Hearing Device Ototronix LLC

Houston, TX

77386

Approval for a manufacturing site change to Biotest Laboratories, Inc. in Minneapolis, Minnesota.
P010025/S020

9/7/10

180-Day

Selenia Dimensions 2D Full Field Digital Mammography System Hologic, Inc.

Bedford, MA

01730

Approval for the Selenia Dimensions 2D Full Field Digital Mammography System.
P010031/S208

9/29/10

Real-Time

Concerto,

Concerto II, Consulta,

Maximo II, Virtuoso, Secura and Virtuoso II

Medtronic, Inc.

Mounds View, MN

55112

Approval for the design changes to NPO-0402 Multilayer Ceramic Capacitors (XC269 and XC313).
P020002/S005

9/16/10

Special

ThinPrep Imaging System Hologic, Inc.

Marlborough, MA

011752

Approval for labeling revisions regarding workload calculation.
P020011/S002

9/17/10

135-Day

Versant HCV RNA Qualitative Assay/ Aptima HCV RNA Qualitative Assay Gen-Probe, Inc.

San Diego, CA

92121

Approval for a change in quality control specifications for the HCV calibrators.
P020026/S078

9/2/10

135-Day

CYPHER® Sirolimus-Eluting Coronary Stent on RAPTOR™ Over-the-Wire Delivery System and RAPTORRAIL® Rapid Exchange Delivery System Cordis Corporation

Miami Lakes, FL

33013

Approval for a change in sampling plan from lot-to-lot to a skip-lot testing plan.
P020027/S012

9/2/10

Real-Time

Dimension® FPSA Flex® Reagent Cartridge Siemens Healthcare Diagnostic, Inc.

Newark, DE 19714

Approval for the addition of a clot check device to the Dimension® EXL™ with LM system when used with the Dimension® FPSA Flex® Reagent Cartridge.
P030005/S070

9/14/10

Real-Time

CONTAK RENEWAL TR CRT-P System Boston Scientific Corporation

St. Paul, MN

55112

Approval for changes to the Model 3120 Programmer System Software Model 2909 from Version 6.01 to version 7.01.
P030009/S039

9/14/10

180-Day

Integrity Coronary Stent System Medtronic Vascular

Santa Rose, CA

95403

Approval for the Integrity Coronary Stent System. The device is indicated for improving

coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions, with reference vessel diameters of 2.25-4.0 mm and ≤30 mm in length, using direct stenting or predilatation.

P030016/S017

9/15/10

Special

Visian Implantable Collamer Lens for Myopia STAAR Surgical Company

Monrovia, CA

91016

Approval for a modification to the Directions for Use to include a warning statement and a modification to a contraindication.
P030029/S009

9/1/10

180-Day

ADVIA® Centaur Anti-HBs (aHBs) Assay on Centaur CP Siemens Healthcare Diagnostics

Tarrytown, NY

10591

Approval for adding quantitative determination of total antibodies to hepatitis B surface antigen in human adult, adolescent, and pediatric serum or plasma to the intended use.

The device, as modified, will be marketed under the trade name ADVIA® Centaur Anti-HBs

(aHBs) Assay on Centaur CP and is indicated for:

ADVIA® Centaur Anti-HBs (aHBs) Assay on the Centaur CP Analyzer:

The ADVIA Centaur Anti-HBs assay is an in vitro diagnostic immunoassay for the qualitative and quantitative determination of total antibodies to hepatitis B surface

antigen in human adult, adolescent, and pediatric serum or plasma (EDTA or heparinized) using the ADVIA Centaur CP System. The assay results may be used as an aid in the

determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to

or following HBV vaccination or where vaccination status is unknown. Assay results may

be used with other HBV serological markers for the laboratory diagnosis of HBV disease

associated with HBV infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown.

P030032/S010

9/15/10

135-Day

PREVELLE Silk Genzyme Biosurgery

Cambridge, MA

02142

Approval for a manufacturing change involving installation of the Waters Empower 2 Chromatography Data System.
P030050/S008

9/9/10

180-Day

Sculptra Aesthetic Sanofi Aventis U.S.

Bridgewater, NJ

08807

Approval of the post-approval study protocol.
P030053/S009

9/14/10

180-Day

Mentor MemoryGel™ Silicone-filled Breast Implant Mentor Corporation

Santa Barbara, CA

93111

Approval of the post-approval study protocol.
P030054/S157

9/23/10

Real-Time

Unify CRT-D St. Jude Medical

Cardiac Rhythm Management Division

Sunnyvale, CA

94086

Approval for changes to the labeling to include longevity information based on additional bench testing.
P030054/S162

9/9/10

180-Day

Atlas II+ HF and Promote CRT-Ds St. Jude Medical

Sylmar, CA

91342

Approval of the post-approval study protocol.
P030054/S165

9/23/10

Real-Time

Epic, Epic+, Epic II, Atlas, Atlas+, Atlas II, Promote, Promote+, Unify CRT-D St. Jude Medical Cardiac Rhythm Management

Sunnyvale, CA

94086

Approval for modifications to the connector blocks including the use of metal injection molding (MIM) and the use of MP35N as the material.
P030054/S170

9/24/10

Real-Time

Quickflex LV Leads and Quickflex µ LV Leads St. Jude Medical

Sylmar, CA

91342

Approval for an increase in inner diameter of the stylet stop feature of the electrode component of the device.
P040023/S016

9/2/10

135-Day

Duraloc Option Ceramic Hip System DePuy Orthopedics, Inc.

Warsaw, IN

46581

Approval for a change to an automated cleaning process and combination of that cleaning process with the final polish process on the firm’s routers.
P040027/S019

9/15/10

135-Day

Gore VIATORR® TIPS Endoprosthesis W.L. Gore & Associates, Inc.

Flagstaff, AZ

86001

Approval for automating the loading of the access sleeve and to use an alternate material vendor.
P050012/S030

9/9/10

Real-Time

DexCom Seven and Seven Plus Continuous Glucose Monitoring System DexCom, Inc.

San Diego, CA

92121

Approval for modification to the sensor needle carrier to reduce force required to release snaps during cannula retraction.
P050012/S031

9/9/10

Real-Time

DexCom Seven and Seven Plus Continuous Glucose Monitoring System DexCom, Inc.

San Diego, CA

92121

Approval for a change from a single to four-cavity production mold as well as the addition of an alternative gate location for the sensor safety lock.
P050028/S004

9/9/10

180-Day

COBAS® AmpliPrep/COBAS® TaqMan® HBV Test, v2.0 Roche Molecular Systems, Inc.

Pleasanton, CA

94588

Approval for a device design modification that includes reagents, disposables,

and instrumentation, to automate the manual sample preparation process currently used by the COBAS® TaqMan® HBV Test For Use With The High Pure System. The device, as modified,

will be marketed under the trade name COBAS® AmpliPrep/ COBAS® TaqMan® HBV Test, v2.0

and is indicated for:

The COBAS® AmpliPrep/COBAS® TaqMan® HBV Test, v2.0 is an in vitro nucleic acid

amplification lest for the quantitation of hepatitis B virus (HBV) DNA in human serum or

plasma (EDTA), using the COBAS® AmpliPrep Instrument for automated specimen processing

and the COBAS® TaqMan® Analyzer or COBAS® TaqMan® 48 Analyzer for automated

amplification and detection.

This test is intended for use as an aid in the management of patients with chronic HBV infection

undergoing antiviral therapy. The test can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. The results from the COBAS®

AmpliPrep/ COBAS® TaqMan1® HBV Test, v2.0 must be interpreted within the context of all

relevant clinical and laboratory findings.

Assay performance characteristics have been established for individuals treated with adefovir

dipivoxil. Assay performance for determining the slate of HBV infection has not been established.

The COBAS® AmpliPrep/ COBAS®TaqMan® HBV Test, v2.0 is not intended for use as a screening test for the presence of HBV in blood or blood products or as a diagnostic test to

confirm the presence of HBV infection.

P050048/S006

9/27/10

135-Day

Bio-Rad Monolisa Anti-HBs EIA Bio-Rad Laboratories

Redmond, WA

98052

Approval for a change in supplier for the hepatitis B antigens used in the manufacture of the device.
P060002/S010

9/15/10

135-Day

Bard® FLAIR® Endovascular Stent Graft Bard Peripheral Vascular, Inc.

Tempe, AZ

85280

Approval for a modification to the procedures for implementing shelf lives of raw materials.
P060027/S026

9/9/10

180-Day

Paradym CRT-D ELA Medical, Inc. / Sorin Group

Plymouth, MN

55441

Approval for revised embedded implant software (version W2.8.4) and revised Smartview programmer softwear (version 2.22 UG2).
P060027/S027

9/14/10

180-Day

Ovatio CRT-D and Situs OTW LV Lead ELA Medical, Inc. / Sorin Group

Plymouth, MN

55441

Approval of the post-approval study protocol.
P060027/S028

9/8/10

Real-Time

Paradym VR/DR and CRT-D ELA Medical, Inc. / Sorin Group

Plymouth, MN

55441

Approval for the design changes for low voltage electronic hybrid module and interconnection flex circuit for Paradym VR/DR and CRT-D, Models 8250, 8550, and 8750.
P060029/S001

9/7/10

Real-Time

Ethicon™ Omnex™ Surgical Sealant (250µl) Ethicon, Inc.

Somerville, NJ

08876

Approval for changes to the applicator and packaging.
P060030/S006

9/1/10

180-Day

COBAS® AmpliPrep / COBAS TaqMan® HCV Test and COBAS® TaqMan® HCV Test, v2.0 for use with the High Pure System Roche Molecular Systems, Inc.

Pleasanton, CA

94588

Approval for a manual specimen preparation option to the currently approved

automated sample preparation method. The device, as modified, will be marketed under the trade name COBAS® TaqMan® HCV Test, v2.0 For Use With The High Pure System and is indicated

for:

The COBAS® TaqMan® HCV Test, v2.0 For Use With The High Pure System is an in vitro

nucleic acid amplification test for the quantitation of hepatitis C virus (HCV) RNA in human plasma or serum of HCV-infected individuals using the High Pure System Viral Nucleic Acid

Kit for manual specimen preparation and the COBAS05® TaqMan® 48 Analyzer for automated

amplification and detection. Specimens containing HCV genotypes 1 through 6 have been

validated for quantitation in the assay.

The COBAS® TaqMan® HCV Test, v2.0 For Use With The High Pure System is intended for use as an aid in the management of HCV-infected individuals undergoing anti-viral therapy. The

assay measures HCV RNA levels at baseline and during treatment and can be used to predict

sustained and non-sustained virological response to HCV therapy. The results from the COBAS®

TaqMan HCV Test, v2.0 For Use With The High Pure System must be interpreted within the context of all relevant clinical and laboratory findings.

Assay performance characteristics have been established for individuals treated with

peginterferon alfa-2a plus ribavirin. No information is available on the assay's predictive value when other therapies are used. Assay performance for determining the state of HCV infection has not been established.

P060040/S008

9/30/10

180-Day

Thoratec HeartMate® II Left Ventricular Assist System (LVAS) Thoratec Corporation

Pleasanton, CA

94588

Approval for a sealed inflow conduit.
P060040/S011

9/13/10

180-Day

HeartMate II® Left Ventricular Assist System (LVAS) Thoratec Corporation

Pleasanton, CA

94588

Approval for updated Instructions for Use (IFU) including post-approval study results.
P070014/S012

9/15/10

135-Day

Bard® Lifestent® Vascular Stent Systems Bard Peripheral Vascular, Inc.

Tempe, Az

85280

Approval for modification to the procedures for implementing shelf lives of raw materials.
P070014/S013

9/14/10

135-Day

Bard® Lifestent® Vascular Stent Systems Bard Peripheral Vascular, Inc.

Tempe, Az

85280

Approval for a modification to a step in the handle assembly process.
P070015/S038

9/15/10

135-Day

XIENCE V™ Everolimus-Eluting Coronary Stent System and PROMUS™ Everolimus-Eluting Coronary Stent System Abbott Vascular

Temecula, CA

92591

Approval for a change to the in-process sampling and testing plan for the primer and drug coating solutions.
P080007/S003

9/15/10

135-Day

E-LUMINEXX® Vascular Stent Bard Peripheral Vascular, Inc.

Tempe, AZ

85280

Approval for modification to the procedures for implementing shelf lives of raw materials.
P080032/S001

9/14/10

180-Day

Alair Bronchial Thermoplasty System Asthmatx, Inc.

Sunnyvale, CA

94089

Approval of the post-approval study protocol.
P090007/S001

9/23/10

180-Day

Elecsys® Anti-HCV Immunoassay & Elecsys ® PreciControl Anti-HCV for use on the Roche cobas e 411 Immunoassay Analyzer Roche Diagnostics Corp.

Indianapolis, IN

46250

Approval for a modification to the device labeling to define the immunoassay cutoff-index above which supplemental recombinant immunoblot assay testing is not required.
P090008/S001

9/23/10

180-Day

Elecsys® Anti-HCV Immunoassay & Elecsys ® PreciControl Anti-HCV for use on the Roche cobas e 601 Immunoassay Analyzer Roche Diagnostics Corp.

Indianapolis, IN

46250

Approval for a modification to the device labeling to define the immunoassay cutoff-index above which supplemental recombinant immunoblot assay testing is not required.
P090009/S001

9/23/10

180-Day

Elecsys® Anti-HCV Immunoassay & Elecsys ® PreciControl Anti-HCV for use on the Modular Analytics E170 Immunoassay Analyzer Roche Diagnostics Corp.

Indianapolis, IN

46250

Approval for a modification to the device labeling to define the immunoassay cutoff-index above which supplemental recombinant immunoblot assay testing is not required.

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

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P790017/S109

9/14/10

Gruntzig Dilaca Balloon Dilatation Catheters Medtronic Vascular

Santa Rosa, CA

95403

Alternate system for measuring extruded tubing.
P810032/S058

9/9/10

PMMA Multi-Piece Posterior Chamber IOLs Alcon Research Ltd.

Fort Worth, TX

76134

Modifications to the sterilant gas distribution and delivery systems.
P810032/S059

9/22/10

PMMA Intraocular Lenses Alcon Research, Ltd.

Fort Worth, TX

76134

Change in the Packaging System.
P840001/S161

9/10/10

Restore® Ultra Medtronic Neuromodulation

Minneapolis, MN

55432

Changes to the brazed and sputtered filtered feedthrough inspection process.
P840001/S162

9/10/10

Itrel® EZ Patient Programmer and Synergy® EZ Patient Programmer Medtronic Neuromodulation

Minneapolis, MN

55432

Change to remove a conditioning procedure from the Patient Programmers’ manufacturing processes.
P840001/S163

9/16/10

Restore ULTRA Implantable Neurostimulator Medtronic Neuromodulation

Minneapolis, MN

55432

Update of the software for the Laser Ribbon Bonding (ORB) processing equipment located at Medtronic’s Puerto Rico Operations Company (MPROC) in Juncos, Puerto Rico.
P840060/S035

9/9/10

PMMA Single-Piece Posterior Chamber IOLs Alcon Research Ltd.

Fort Worth, TX

76134

Modifications to the sterilant gas distribution and delivery systems.
P840060/S036

9/22/10

PMMA Intraocular Lenses Alcon Research, Ltd.

Fort Worth, TX

76134

Change in the Packaging System.
P860004/S137

9/1/10

SynchroMed Infusion Systems – Alarm Test Software Medtronic Neuromodulation

Minneapolis, MN

44532

Change to lengthen the time for measuring the alarm output of the “Alarm Test” of the device.
P860019/S260

9/1/10

PTCA Catheters (Maverick 2, Maverick®, Maverick® XL, Quantum™ Maverick®, and APEX®) Boston Scientific Corporation

Maple Grove, MN

55311

Reduction of in-process destructive testing and associated measurements performed on the balloon components of the devices during the balloon molding operation.
P860019/S261

9/8/10

Maverick 2™ Monorail® PTCA Dilation Catheters Boston Scientific Corporation

Maple Grove, MN

55311

Alternate sterilization cycle to be used at Isotron, Tullamore, Ireland.
P860019/S263

9/8/10

Apex PTCA and NC Quantum Apex PTCA Catheters Boston Scientific Corporation

Maple Grove, MN

55311

Changes to the in-process monitoring requirements.
P880087/S017

9/9/10

PMMA Single-Piece Anterior Chamber IOLs Alcon Research Ltd.

Fort Worth, TX

76134

Modifications to the sterilant gas distribution and delivery systems.
P880087/S018

9/22/10

PMMA Single-Piece Anterior Chamber IOLs Alcon Research, Ltd.

Fort Worth, TX

76134

Change in the Packaging System.
P910073/S086

9/8/10

Endotak Reliance Family of Leads Boston Scientific Corporation

St. Paul, MN

55112

Change in the Manufacturing Automated Traceability Tracking (MATT) system used during the manufacturing of leads.
P910077/S107

9/29/10

6481 Latitude Inductive Communicator, 6482 Lattitude RF Communicator, 3120 Programmer/ Recorder/Monitor (PRM) Boston Scientific Corp.

St. Paul, MN

55112

New soldering equipment and site relocation for printed circuit boards supplier.
P920023/S027

9/30/10

AMS UroLume Endoprosthesis American Medical Systems, Inc.

Minnetonka, MN

55343

Change in a measurement method used during receiving/ inspection.
P930014/S042

9/9/10

AcrySof® Monofocal and AcrySof® Toric Posterior Chamber IOLs and AcrySert® Delivery System Alcon Research Ltd.

Fort Worth, TX

76134

Modifications to the sterilant gas distribution and delivery systems.
P930014/S043

9/17/10

AcrySof® and AcrySof IQ Toric Intraocular Lenses Alcon Research, Ltd.

Fort Worth, TX

76134

Use of a new Toric Lens Bench Gauge (Renishaw).
P930014/S044

9/22/10

AcrySof® Intraocular Lenses Alcon Research, Ltd.

Fort Worth, TX

76134

Change in the Packaging System.
P950034/S033

9/14/10

Seprafilm Adhesion Barrier Genzyme Corporation

Cambridge, MA

02142

Addition of a new procedure for the Seprafilm labeling and packaging.
P950037/S085

9/10/10

Philos and Philos II Families of IPGs Biotronik, Inc.

Lake Oswego, OR

97035

Alternate joining process of pulse generator housings.
P950037/S086

9/17/10

Philos DR, Philos DR-B, Philos SR, Philos SR-B, Philos DR-T, Philos II

DR, Philos II DR-T, Philos II SR, Cylos DR, Cylos DR-T, Cylos VR, Evia

DR, Evia DR-T, Evia SR, Evia SR-T, Entovis DR-T, Entovis DR, Entovis

SR, and Entovis SR-T PGs; Selox JT, Selox ST, Dextrus, Setrox S, SLS

xxxx-BP, and Selox SR Electrodes; CardioMessenger LLT, ICS 3000, and

EDP30

Biotronik, Inc.

Lake Oswego, OR

97035

New labeling software used to print the labels for various devices and accessories.
P960004/S046

9/22/10

Thinline II ASterox, Thinline Sterox EZ, Fineline II Sterox, and Fineline II Sterox EZ Boston Scientific Corporation

St. Paul, MN

55112

Change to the shelf-life expiration of polyurethane tubing from 36 months to “indefinite”.
P960009/S093

9/10/10

Activa® RC Medtronic Neuromodulation

Minneapolis, MN

55432

Changes to the brazed and sputtered filtered feedthrough inspection process.
P960009/S094

9/10/10

Access® Therapy Controller Medtronic Neuromodulation

Minneapolis, MN

55432

Change to remove a conditioning procedure from the Patient Programmers’ manufacturing processes.
P960009/S095

9/16/10

Activa RC Deep Brain Stimulator Medtronic Neuromodulation

Minneapolis, MN

55432

Update of the software for the Laser Ribbon Bonding (ORB) processing equipment located at Medtronic’s Puerto Rico Operations Company (MPROC) in Juncos, Puerto Rico.
P960016/S032

9/10/10

Livewire TC Cardiac Ablation System St. Jude Medical, Inc.

Minnetonka, MN

55345

Changes to the Livewire TC steerable catheter subassembly process.
P960040/S228

9/3/10

Confient Boston Scientific Corporation

St. Paul, MN

55112

Changes to test software used to perform electrical testing of Integrated Circuits used in pulse generators.
P960040/S229

9/2/10

Vitality, Confient and Teligen Boston Scientific Corporation

St. Paul, MN

55112

Change to the supplied pin length and welding process used in the anode assembly manufacturing process.
P960040/S230

9/8/10

Teligen Implantable Cardioverter defibrillator (ICD) Boston Scientific Corporation

St. Paul, MN

55112

Addition of a 100% pass/fail inspection for capacitors during manufacturing.
P960040/S231

9/14/10

Confient ICDs Boston Scientific Corporation

St. Paul, MN

55112

Change to the thermode blade wing.
P960040/S232

9/17/10

Vitality, Prizm, Confient, Teligen Boston Scientific Corporation

St. Paul, MN

55112

Addition of heptane as a solvent in the pulse generator cleaning step.
PP960040

9/22/10

Confient RF-1 HE IS-2 AV and Teligen HE VR DR-1 Boston Scientific Corporation

St. Paul, MN

55112

Change to the shelf-life expiration of polyurethane tubing from 36 months to “indefinite”.
P960042/S019

9/1/10

Spectranetics Laser Sheath II Products Spectranetics

Colorado Springs, CO

80921

Change to the polishing process for the SLS laser sheath distal tip.
P960042/S020

9/15/10

SLS II Laser Sheath Spectranetics Corporation

Colorado Springs, CO

80921

Removal of a QC step that verifies the fiber bundle alignment.
P960042/S021

9/15/10

Spectranetics SLS II Laser Sheath Spectranetics Corporation

Colorado Springs, CO

80921

Change in the labeling process.
P970003/S113

9/10/10

VNS Therapy® Systems Cyberonics, Inc.

Houston, TX

77058

Addition of a supplier in the sterilization process.
P970004/S091

9/10/10

InterStim® Patient Programmer Medtronic Neuromodulation

Minneapolis, MN

55432

Change to remove a conditioning procedure from the Patient Programmers’ manufacturing processes.
P970027/S009

9/20/10

AxSYM Anti-HCV Abbott Laboratories

Abbott Park, IL

60064

Modifications to the quality control test method used to determine a specific attribute of the AxSYM Anti-HCV solution based components.
P980022/S082

9/9/10

Paradigm Real Time Insulin Pump Medtronic, Inc.

Northridge, CA

91325

Additional supplier of the molded plastic components used in the manufacture of the Paradigm Pump (MMT-522, MMT-522K, MMT-523, MMT-523K).
P980035/S186

9/9/10

Adapta/Versa/ Sensia, Relia IPGs Medtronic, Inc.

Mounds View, MN

55112

Additional supplier for the plating process.
P980035/S187

9/8/10

Sigma, Medtronic 350, EnRhythm and AT500 IPGs Medtronic, Inc.

Cardiac Rhythm and Disease Management

Mounds View, MN

55112

Change to the Brazed and Sputtered Filtered Feedthrough inspection process.
P990001/S076

9/8/10

InSync III CRT-P Medtronic, Inc.

Cardiac Rhythm and Disease Management

Mounds View, MN

55112

Change to the Brazed and Sputtered Filtered Feedthrough inspection process.
P990009/S030

9/3/10

Floseal Hemostatic Matrix Baxter Healthcare Corporation

McGaw Park, IL

60085

Modification of the thawing process for a component of the device.
P990064/S034

9/8/10

Mosaic Bioprosthesis Medtronic, Inc.

Santa Ana, CA

92705

Modification to the contour ring and sizing pressure.
P000009/S041

9/17/10

Lexos DR, Lexos DR-T, Lexos VR, Lexos VR-T, Lumos DR-T, and

Lumos VR-T ICDs

Biotronik, Inc.

Lake Oswego, OR

97035

New labeling software used to print the labels for various devices and accessories.
P000010/S017

9/23/10

AMPLICOR HCV Test Roche Molecular Systems, Inc.

Pleasanton, CA

94566

Changes to reduce the batch size for manufacture of Substrate A, Subatrate B, Stop Reagent and Wash Concentrate bulk solution.
P000012/S025

9/23/10

COBAS AMPLICOR HCV Test, Version 2.0 and COBAS AmpliPrep/COBAS AMPLICOR HCV Test Roche Molecular Systems, Inc.

Pleasanton, CA

94566

Changes to reduce the batch size for manufacture of Substrate A, Subatrate B, Stop Reagent and Wash Concentrate bulk solution.
P000025/S049

9/17/10

COMBI 40+ Cochlear Implant System MED-EL Corporation

Durham, NC

27713

Implementation of a quality assurance inspection step for the incoming inspection of the liquid silicone rubber.
P010012/S248

9/3/10

Contak Renewal and Livian Boston Scientific Corporation

St. Paul, MN

55112

Changes to test software used to perform electrical testing of Integrated Circuits used in pulse generators.
P010012/S249

9/2/10

Contak Renewal, Livian and Cognis Boston Scientific Corporation

St. Paul, MN

55112

Change to the supplied pin length and welding process used in the anode assembly manufacturing process.
P010012/S250

9/8/10

Cognis Implantable Cardiac Resynchronization Therapy Defibrillator

(CRT-D)

Boston Scientific Corporation

St. Paul, MN

55112

Addition of a 100% pass/fail inspection for capacitors during manufacturing.
P010012/S251

9/14/10

Contak Renewal 3 and Livian CRT-Ds Boston Scientific Corporation

St. Paul, MN

55112

Change to the thermode blade wing.
P010012/S252

9/17/10

Livian, Renewal, Cognis Boston Scientific Corporation

St. Paul, MN

55112

Addition of heptane as a solvent in the pulse generator cleaning step.
P010012/S253

9/22/10

Easytrak 2, Easytrak 3, Easytrak 2 IS-1, Easytrak 3 IS-1, Acuity Spiral, Contak Renewal 3 RF, Contak Renewal 3 RF HE, Livian RF-1 SE, Livian RF-1 HE, and Cognis. Boston Scientific Corporation

St. Paul, MN

55112

Change to the shelf-life expiration of polyurethane tubing from 36 months to “indefinite”.
P010015/S099

9/8/10

Dema, C-series, and T-series IPGs Medtronic, Inc.

Cardiac Rhythm and Disease Management

Mounds View, MN

55112

Change to the Brazed and Sputtered Filtered Feedthrough inspection process.
P010019/S018

9/2/10

Lotrafilcon Soft Contact Lenses for Extended Wear Ciba Vision Corporation

Duluth, GA

30097

Shelf life extension for contact lens material formulations.
P010019/S019

9/8/10

Ciba Vision® (lotrafilcon B) Soft Contact Lens Ciba Vision Corporation

Duluth, GA

30097

Change to eliminate the staging/hold time for the device.
P010030/S022

9/1/10

LifeVest® Wearable Defibrillator Zoll Lifecor Corporation

Pittsburgh, PA

15238

New test texture for the functional testing of the electrode belt.
P020004/S055

9/15/10

Gore® Excluder® AAA Endoprosthesis W.L. Gore & Associated, Inc.

Flagstaff, AZ

86001

Changes to the sterilization cycle process.
P020011/S004

9/17/10

VERSANT® HCV RNA Qualitative Assay/APTIMA® HCV RNA Qualitative Assay Gen-Probe, Inc.

San Diego, CA

92121

Modification to the purification and desalting processes for two classes of oligonucleotides (RXL Intermediates and PPOs), which are components of some reagents of the device.
P020036/S019

9/2/10

Smart® Nitinol Stent System and Smart® Control Nitinol Stent Systems Cordis Corporation

Miami Lakes, FL

33014

Discontinuance of a final packaging inspection.
P020045/S034

9/17/10

Freezor®, Freezor® Xtra Surgical and Freezor® MAX Surgical Catheters and CryoConsole Medtronic AF Solutions

Mounds View, MN

55112

Alternate components for the manufacturing of printed circuit board assemblies.
P030005/S068

9/3/10

Contak Renewal TR Boston Scientific Corporation

St. Paul, MN

55112

Changes to test software used to perform electrical testing of Integrated Circuits used in pulse generators.
P030005/S069

9/17/10

Renewal Boston Scientific Corporation

St. Paul, MN

55112

Addition of heptane as a solvent in the pulse generator cleaning step.
P030009/S044

9/14/10

Driver and Micro Driver Coronary Stent Systems Medtronic Vascular

Santa Rosa, CA

95403

Alternate system for measuring extruded tubing.
P030017/S107

9/3/10

Precision Spinal Cord Stimulator (SCS) System Boston Scientific Neuromodulation Corp.

Valencia, CA

91355

Addition of an alternate supplier for certain components.
P030047/S022

9/2/10

Precise®, Precise® RX, and Precise® PRO Rx Nitinol Stent Systems Cordis Corporation

Miami Lakes, FL

33014

Discontinuance of a final packaging inspection.
P040016/S062

9/1/10

VeriFLEX (Liberté®) Stent Delivery System Boston Scientific Corporation

Maple Grove, MN

55311

Reduction of in-process destructive testing and associated measurements performed on the balloon components of the devices during the balloon molding operation.
P040020/S026

9/9/10

AcrySof® Multifocal Posterior Chamber Intraocular Lenses (IOLs) Alcon Research Ltd.

Fort Worth, TX

76134

Modifications to the sterilant gas distribution and delivery systems.
P040020/S027

9/22/10

AcrySof® Intraocular Lenses Alcon Research, Ltd.

Fort Worth, TX

76134

Change in the Packaging System.
P040027/S021

9/1/10

Gore Viatorr® TIPS Endoprosthesis W.L. Gore & Associates, Inc.

Flagstaff, AZ

86001

Modification to the terminating wire attachment process.
P040027/S022

9/1/10

Gore Viatorr® TIPS Endoprosthesis W.L. Gore & Associates, Inc.

Flagstaff, AZ

86001

Modification of the process parameters for one of the EO sterilization cycles.
P040034/S017

9/16/10

DuraSeal Dural Sealant system Covidien

Bedford, MA

01730

Addition of an alternate lab for testing certain raw materials.
P040037/S028

9/8/10

Gore® Viabahn® Endoprosthesis W.L. Gore & Associated, Inc.

Flagstaff, AZ

86001

Automation of a manufacturing process.
P040037/S029

9/15/10

Gore® Viabahn® Endoprosthesis W.L. Gore & Associated, Inc.

Flagstaff, AZ

86001

Changes to the sterilization cycle process.
P040043/S036

9/15/10

Gore® Tag® Thoracic Endoprosthesis W.L. Gore & Associated, Inc.

Flagstaff, AZ

86001

Changes to the sterilization cycle process.
P040045/S015

9/24/10

Vistakon® (senofilcon A) Contact Lenses, Clear and Visibility Tinted with UV Blocker Johnson & Johnson Vision Care, Inc.

Jacksonville, FL

32256

Change to the Oxygen Permeability Test Method TM-0534.
P050006/S018

9/15/10

Gore® Helex Septal Occluder W.L. Gore & Associated, Inc.

Flagstaff, AZ

86001

Changes to the sterilization cycle process.
P050018/S010

9/8/10

AngioSculpt® PTCA Scoring Balloon Catheters AngioScore, Inc.

Fremont, CA

94538

Alternate supplier for the nitinol scoring element.
P050023/S037

9/17/10

Lumax 300 DR-T, Lumax 340 DR-T, Lumax 300 VR-T, Lumax 340 VRT,

Lumax 500 DR-T, Lumax 540 DR-T, Lumax 500 VR-T, Lumax 540

VR-T, Lumax 540 VR-T DX, Lumax 300 HF-T, Lumax 340 HF-T,

Lumax 500 HF-T, and Lumax 540 HF-T PGs; Corox OTW UP Steroid

Electrode, CardioMessenger II, CardioMessenger II-LLT,

CardioMessenger -Tline, CardioMessenger II-S, CardioMessenger II-S TLine, CardioMessenger S, and CardioMessenger S TLine

Biotronik, Inc.

Lake Oswego, OR

97035

New labeling software used to print the labels for various devices and accessories.
P050046/S007

9/22/10

Acuity Steerable Boston Scientific Corporation

St. Paul, MN

55112

Change to the shelf-life expiration of polyurethane tubing from 36 months to “indefinite”.
P050047/S012

9/14/10

Juvéderm Hyaluronate Gel Implants Allergan

Goleta, CA

93117

Change in the packaging process.
P050047/S013

9/24/10

Juvéderm Hyaluronate Gel Implants Allergan

Goleta, CA

93117

Change in fill volume for the device.
P060002/S015

9/8/10

Bard Flair® Endovascular Stent Graft Bard Peripheral Vascular, Inc.

Tempe, AZ

85280

Upgrade to the maintenance management software program used to track and schedule preventative maintenance talk, equipment, and supplies.
P060002/S016

9/8/10

Bard Flair® Endovascular Stent Graft Bard Peripheral Vascular, Inc.

Tempe, AZ

85280

Updates to the environmental storage specifications for the raw material used in manufacturing.
P060006/S015

9/1/10

Express® SD Premounted Stent System Boston Scientific Corporation

Maple Grove, MN

55311

Reduction of in-process destructive testing and associated measurements performed on the balloon components of the devices during the balloon molding operation.
P060008/S058

9/1/10

TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation

Maple Grove, MN

55311

Reduction of in-process destructive testing and associated measurements performed on the balloon components of the devices during the balloon molding operation.
P060030/S014

9/22/10

COBAS AmpliPrep/ COBAS TaqMan HCV Test Roche Molecular Systems, Inc.

Pleasanton, CA

94588

Changes to release testing procedures used in the CAP/CTM HCV Test.
P060033/S057

9/1/10

Endeavor Zotarolimus-Eluting Coronary Stent Systems and Endeavor Sprint Zotarolimus-Eluting Coronary Stent Systems Medtronic Vascular

Santa Rosa, CA

95403

Change to sterilization load configuration.
P060033/S058

9/14/10

Endeavor Sprint Zotarolimus-Eluting Coronary Stent System Medtronic Vascular

Santa Rosa, CA

95403

Alternate system for measuring extruded tubing.
P070008/S018

9/17/10

Stratos LV and Stratos LV-T CRT-Ps; and Corox OTW(-S) BP Electrode Biotronik, Inc.

Lake Oswego, OR

97035

New labeling software used to print the labels for various devices and accessories.
P070015/S044

9/2/10

XIENCE V™ Everolimus Eluting Coronary Stent System and PROMUS™ Everolimus Eluting Coronary Stent System Abbott Vascular

Temecula, CA

92591

Change in the number of stents pooled for analytical release testing.
P080007/S004

9/8/10

Bard® ELUMINEXX® Vascular Stent Bard Peripheral Vascular, Inc.

Tempe, AZ

85280

Revised formulation for the adhesive used during manufacturing.
P080032/S003

9/30/10

Alair Bronchial Thermoplasty System Asthmatx, Inc.

Sunnyvale, CA

94089

Addition of a new test method for impedance measurement accuracy.
P090018/S005

9/8/10

Esteem Envoy Medical Corporation

St. Paul, MN

55110

Change the manufacture of the Ear Insert Assembly and Microphone Assembly.
P090018/S007

9/21/10

Esteem Envoy Medical Corporation

St. Paul, MN

55110

Changes for the personal programmer.

Summary of PMA Originals & Supplements Approved

Originals: 0

Supplements: 79

Summary of PMA Originals Under Review

Total Under Review: 93

Total Active: 40

Total On Hold: 53

Number Greater Than 180 Days: 5

Summary of PMA Supplements Under Review

Total Under Review: 629

Total Active: 436

Total On Hold: 193

Number Greater Than 180 Days: 16

Summary of All PMA Submissions Received

Originals: 4

Supplements: 67

Summary of PMA Supplement PMA Approval/Denial Decision Times

Number of Approvals: 79

Number of Denials: 0

Average Days Fr Receipt to Decision (Total Time): 120.6

FDA Time: 87.9 Days MFR Time: 32.7 Days

    

SOURCE

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