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PMA Final Decisions for September 2010

Posted Oct 18 2010 9:00pm

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 APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P840068/S047
9/14/10
Real-Time
DELTA Pacemaker SystemBoston 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 ConnectorMedtronic 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 SystemBoston 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/DRSt. 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 PromoteSt. 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/DRSt. 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 LeadsBoston 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 SystemBoston 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® EndoprosthesisAmerican 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-OneGenzyme 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 SystemBoston 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 SystemTripath 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 LeadsSt. Jude Medical
Sylmar, CA
91342
Approval of the post-approval study protocol.
P950037/S079
9/2/10
180-Day
Reliaty/Model 3145 Pacing System AnalyzerBiotronik, 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 ICDsBoston 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 SystemBoston 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 SystemAdvanced 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 SystemCyberonics, 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 SystemBoston 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 LeadsBiotronik, 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 VRELA 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-DELA 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 DeviceVascular 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 SystemCodman & 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 CartridgeSiemens 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 SystemMED-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 SystemMED-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 GelOceana 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 SystemCooper 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 SystemCooper 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 ValveOn-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 SystemCeramTec 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 SystemCeramTec 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-DBoston 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-DsBoston 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 SystemBoston 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 DeviceOtotronix 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 DeviceOtotronix 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 SystemHologic, 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 SystemHologic, 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 AssayGen-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 SystemCordis 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 CartridgeSiemens 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 SystemBoston 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 SystemMedtronic 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 MyopiaSTAAR 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 CPSiemens 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 SilkGenzyme 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 AestheticSanofi 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 ImplantMentor Corporation
Santa Barbara, CA
93111
Approval of the post-approval study protocol.
P030054/S157
9/23/10
Real-Time
Unify CRT-DSt. 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-DsSt. 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-DSt. 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 LeadsSt. 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 SystemDePuy 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 EndoprosthesisW.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 SystemDexCom, 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 SystemDexCom, 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, v2.0Roche 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 EIABio-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 GraftBard 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-DELA 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 LeadELA 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-DELA 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 SystemRoche 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 SystemsBard 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 SystemsBard 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 SystemAbbott 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 StentBard 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 SystemAsthmatx, 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 AnalyzerRoche 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 AnalyzerRoche 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 AnalyzerRoche 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.
APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P790017/S109
9/14/10
Gruntzig Dilaca Balloon Dilatation CathetersMedtronic Vascular
Santa Rosa, CA
95403
Alternate system for measuring extruded tubing.
P810032/S058
9/9/10
PMMA Multi-Piece Posterior Chamber IOLsAlcon Research Ltd.
Fort Worth, TX
76134
Modifications to the sterilant gas distribution and delivery systems.
P810032/S059
9/22/10
PMMA Intraocular LensesAlcon Research, Ltd.
Fort Worth, TX
76134
Change in the Packaging System.
P840001/S161
9/10/10
Restore® UltraMedtronic 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 ProgrammerMedtronic Neuromodulation
Minneapolis, MN
55432
Change to remove a conditioning procedure from the Patient Programmers’ manufacturing processes.
P840001/S163
9/16/10
Restore ULTRA Implantable NeurostimulatorMedtronic 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 IOLsAlcon Research Ltd.
Fort Worth, TX
76134
Modifications to the sterilant gas distribution and delivery systems.
P840060/S036
9/22/10
PMMA Intraocular LensesAlcon Research, Ltd.
Fort Worth, TX
76134
Change in the Packaging System.
P860004/S137
9/1/10
SynchroMed Infusion Systems – Alarm Test SoftwareMedtronic 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 CathetersBoston 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 CathetersBoston Scientific Corporation
Maple Grove, MN
55311
Changes to the in-process monitoring requirements.
P880087/S017
9/9/10
PMMA Single-Piece Anterior Chamber IOLsAlcon 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 IOLsAlcon Research, Ltd.
Fort Worth, TX
76134
Change in the Packaging System.
P910073/S086
9/8/10
Endotak Reliance Family of LeadsBoston 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 EndoprosthesisAmerican 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 SystemAlcon 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 LensesAlcon Research, Ltd.
Fort Worth, TX
76134
Use of a new Toric Lens Bench Gauge (Renishaw).
P930014/S044
9/22/10
AcrySof® Intraocular LensesAlcon Research, Ltd.
Fort Worth, TX
76134
Change in the Packaging System.
P950034/S033
9/14/10
Seprafilm Adhesion BarrierGenzyme 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 IPGsBiotronik, 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 EZBoston 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® RCMedtronic Neuromodulation
Minneapolis, MN
55432
Changes to the brazed and sputtered filtered feedthrough inspection process.
P960009/S094
9/10/10
Access® Therapy ControllerMedtronic 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 StimulatorMedtronic 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 SystemSt. Jude Medical, Inc.
Minnetonka, MN
55345
Changes to the Livewire TC steerable catheter subassembly process.
P960040/S228
9/3/10
ConfientBoston 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 TeligenBoston 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 ICDsBoston Scientific Corporation
St. Paul, MN
55112
Change to the thermode blade wing.
P960040/S232
9/17/10
Vitality, Prizm, Confient, TeligenBoston 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-1Boston 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 ProductsSpectranetics
Colorado Springs, CO
80921
Change to the polishing process for the SLS laser sheath distal tip.
P960042/S020
9/15/10
SLS II Laser SheathSpectranetics 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 SheathSpectranetics Corporation
Colorado Springs, CO
80921
Change in the labeling process.
P970003/S113
9/10/10
VNS Therapy® SystemsCyberonics, Inc.
Houston, TX
77058
Addition of a supplier in the sterilization process.
P970004/S091
9/10/10
InterStim® Patient ProgrammerMedtronic Neuromodulation
Minneapolis, MN
55432
Change to remove a conditioning procedure from the Patient Programmers’ manufacturing processes.
P970027/S009
9/20/10
AxSYM Anti-HCVAbbott 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 PumpMedtronic, 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 IPGsMedtronic, Inc.
Mounds View, MN
55112
Additional supplier for the plating process.
P980035/S187
9/8/10
Sigma, Medtronic 350, EnRhythm and AT500 IPGsMedtronic, 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-PMedtronic, 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 MatrixBaxter Healthcare Corporation
McGaw Park, IL
60085
Modification of the thawing process for a component of the device.
P990064/S034
9/8/10
Mosaic BioprosthesisMedtronic, 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 TestRoche 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 TestRoche 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 SystemMED-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 LivianBoston 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 CognisBoston 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-DsBoston Scientific Corporation
St. Paul, MN
55112
Change to the thermode blade wing.
P010012/S252
9/17/10
Livian, Renewal, CognisBoston 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 IPGsMedtronic, 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 WearCiba Vision Corporation
Duluth, GA
30097
Shelf life extension for contact lens material formulations.
P010019/S019
9/8/10
Ciba Vision® (lotrafilcon B) Soft Contact LensCiba Vision Corporation
Duluth, GA
30097
Change to eliminate the staging/hold time for the device.
P010030/S022
9/1/10
LifeVest® Wearable DefibrillatorZoll Lifecor Corporation
Pittsburgh, PA
15238
New test texture for the functional testing of the electrode belt.
P020004/S055
9/15/10
Gore® Excluder® AAA EndoprosthesisW.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 AssayGen-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 SystemsCordis 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 CryoConsoleMedtronic AF Solutions
Mounds View, MN
55112
Alternate components for the manufacturing of printed circuit board assemblies.
P030005/S068
9/3/10
Contak Renewal TRBoston 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
RenewalBoston 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 SystemsMedtronic Vascular
Santa Rosa, CA
95403
Alternate system for measuring extruded tubing.
P030017/S107
9/3/10
Precision Spinal Cord Stimulator (SCS) SystemBoston 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 SystemsCordis Corporation
Miami Lakes, FL
33014
Discontinuance of a final packaging inspection.
P040016/S062
9/1/10
VeriFLEX (Liberté®) Stent Delivery SystemBoston 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 LensesAlcon Research, Ltd.
Fort Worth, TX
76134
Change in the Packaging System.
P040027/S021
9/1/10
Gore Viatorr® TIPS EndoprosthesisW.L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Modification to the terminating wire attachment process.
P040027/S022
9/1/10
Gore Viatorr® TIPS EndoprosthesisW.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 systemCovidien
Bedford, MA
01730
Addition of an alternate lab for testing certain raw materials.
P040037/S028
9/8/10
Gore® Viabahn® EndoprosthesisW.L. Gore & Associated, Inc.
Flagstaff, AZ
86001
Automation of a manufacturing process.
P040037/S029
9/15/10
Gore® Viabahn® EndoprosthesisW.L. Gore & Associated, Inc.
Flagstaff, AZ
86001
Changes to the sterilization cycle process.
P040043/S036
9/15/10
Gore® Tag® Thoracic EndoprosthesisW.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 BlockerJohnson & Johnson Vision Care, Inc.
Jacksonville, FL
32256
Change to the Oxygen Permeability Test Method TM-0534.
P050006/S018
9/15/10
Gore® Helex Septal OccluderW.L. Gore & Associated, Inc.
Flagstaff, AZ
86001
Changes to the sterilization cycle process.
P050018/S010
9/8/10
AngioSculpt® PTCA Scoring Balloon CathetersAngioScore, 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 SteerableBoston 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 ImplantsAllergan
Goleta, CA
93117
Change in the packaging process.
P050047/S013
9/24/10
Juvéderm Hyaluronate Gel ImplantsAllergan
Goleta, CA
93117
Change in fill volume for the device.
P060002/S015
9/8/10
Bard Flair® Endovascular Stent GraftBard 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 GraftBard 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 SystemBoston 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 SystemBoston 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 TestRoche 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 SystemsMedtronic Vascular
Santa Rosa, CA
95403
Change to sterilization load configuration.
P060033/S058
9/14/10
Endeavor Sprint Zotarolimus-Eluting Coronary Stent SystemMedtronic 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 ElectrodeBiotronik, 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 SystemAbbott Vascular
Temecula, CA
92591
Change in the number of stents pooled for analytical release testing.
P080007/S004
9/8/10
Bard® ELUMINEXX® Vascular StentBard Peripheral Vascular, Inc.
Tempe, AZ
85280
Revised formulation for the adhesive used during manufacturing.
P080032/S003
9/30/10
Alair Bronchial Thermoplasty SystemAsthmatx, Inc.
Sunnyvale, CA
94089
Addition of a new test method for impedance measurement accuracy.
P090018/S005
9/8/10
EsteemEnvoy Medical Corporation
St. Paul, MN
55110
Change the manufacture of the Ear Insert Assembly and Microphone Assembly.
P090018/S007
9/21/10
EsteemEnvoy 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

    
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