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FDA releases September PMAs

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The Food & Drug Administration released a list of pre-market approvals granted in September:

PMA Original Approvals

None.

PMA Supplemental Approvals

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

Filed Under: Uncategorized

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