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U.S. Department of Health and Human Services

Medical Devices

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September 2011 PMA Approvals

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.

PMA Original Approvals

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P110003
9/28/11
LeGoo®Pluromed, Inc.
Woburn, MA
01801
Approval for the LeGoo®. This device is indicated for temporary endovascular occlusion of blood vessels below the neck up to 4 mm in diameter.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P830060/S067
9/1/11
Real-Time
Reliance 4-Site Leads and AccessoriesBoston Scientific
St. Paul, MN
55112
Approval for design changes to the Terminal Tool (renamed EZ-4 Connector Tool), design change to the lead and tool packaging, and various labeling changes.
P860057/S079
9/21/11
135-Day
Carpentier-Edwards PERIMOUNT Pericardial Bioprosthetic WireformEdwards Lifesciences, LLC
Irvine, CA
92614
Approval for new eddy current test equipment.
P880006/S073
9/8/11
Real-Time
Sensolog/Dialog/ Regency Family of PacemakersSt. Jude Medical
Sylmar, CA
91342
Approval for Model 3330 version 13.1 programmer software which includes enhancements to the layout/design of the existing Merlin PCS printed reports.
P880006/S074
9/28/11
Real-Time
Merlin Patient Care SystemSt. Jude Medical
Sylmar, CA
91342
Approval for the Model 3330 Version 12.1.10 Software for the Model 3650 Merlin Patient Care System.
P880086/S208
9/8/11
Real-Time
Affinity/Integrity/ Victory/Zephyr/ Accent Family of PacemakersSt. Jude Medical
Sylmar, CA
91342
Approval for Model 3330 version 13.1 programmer software which includes enhancements to the layout/design of the existing Merlin PCS printed reports.
P880086/S209
9/28/11
Real-Time
Merlin Patient Care SystemSt. Jude Medical
Sylmar, CA
91342
Approval for the Model 3330 Version 12.1.10 Software for the Model 3650 Merlin Patient Care System
P910007/S031
9/13/11
Special
AxSYM Total PSA and ARCHITECT Total PSAAbbott Laboratories
Abbott Park, IL
60064
Approval for addition of a BSA screening test to identify protease contamination in vendor lots of incoming BSA prior to purchase.
P910023/S265
9/20/11
135-Day
Cadence Family of ICDsSt. Jude Medical, Inc.
Sylmar, CA
91342
Approval for an alternate supplier of a circuit component.
P910023/S271
9/8/11
Real-Time
Fortify ICDSt. Jude Medical, Inc.
Sunnyvale, CA
94086
Approval for changes to the controller integrated circuits for the devices.
P910023/S272
9/8/11
Real-Time
Cadence/Current Family of ICDsSt. Jude Medical
Sylmar, CA
91342
Approval for Model 3330 version 13.1 programmer software which includes enhancements to the layout/design of the existing Merlin PCS printed reports.
P910023/S273
9/28/11
Real-Time
Merlin Patient Care SystemSt. Jude Medical
Sylmar, CA
91342
Approval for the Model 3330 Version 12.1.10 Software for the Model 3650 Merlin Patient Care System.
P910073/S094
9/1/11
Real-Time
Reliance 4-Site Leads and AccessoriesBoston Scientific
St. Paul, MN
55112
Approval for design changes to the Terminal Tool (renamed EZ-4 Connector Tool), design change to the lead and tool packaging, and various labeling changes.
P950020/S042
9/23/11
135-Day
Flextome Cutting BalloonBoston Scientific Corporation
Maple Grove, MN
55311
Approval to update the gel rating specification scale used for resin material acceptance.
P950032/S064
9/22/11
Real-Time
Apligraf (Graftskin)Organogenesis, Inc.
Canton, MA
02021
Approval for the introduction of Human Dermal Fibroblast cell strain (HDF 072) into the manufacture of Apligraf.
P950037/S098
9/30/11
180-Day
Renamic Programmer and SoftwareBiotronik, Inc.
Lake Oswego, OR
97035
Approval for the Renamic Programmer and Software Version PSW 1101.U.
P960007/S021
9/20/11
180-Day
TransCyte®Advanced BioHealing, Inc.
LaJolla, CA
92037
Approval for changing from the use of fetal bovine serum to the use of bovine calf serum as a media supplement for expanding cells in expanded surface roller bottles, i.e., the Cell Expansion process.
P960043/S075
9/23/11
Real-Time
Perclose AT and ProGlide Suture-Mediated Closure SystemsAbbott Vascular
Redwood City, CA
94063
Approval for an alternate material for manufacturing the Tensioner component.
P960058/S090
9/12/11
135-Day
Auria Harmony Hiresolution Bionic Ear SystemAdvanced Bionics, LLC
Sylmar, CA
91342
Approval for a change to the manufacturing process to increase the thickness to dielectric layers of the substrate and is indicated to provide useful hearing to individuals with severe-to-profound sensorineural hearing loss.
P970013/S042
9/8/11
Real-Time
Microny Family of PacemakersSt. Jude Medical
Sylmar, CA
91342
Approval for Model 3330 version 13.1 programmer software which includes enhancements to the layout/design of the existing Merlin PCS printed reports.
P970013/S043
9/28/11
Real-Time
Merlin Patient Care SystemSt. Jude Medical
Sylmar, CA
91342
Approval for the Model 3330 Version 12.1.10 Software for the Model 3650 Merlin Patient Care System.
P970018/S024
9/21/11
Special
PrepStain™ System/ PrepMate™BD Diagnostics
Durham, NC
27703
Approval for updating the product labeling and the PrepMate Operator Manual. Requested changes to the product labeling include updating the MET mark, updating the
manufacturing address and EC authorized representative name and address, adding CE mark, and adding BD branding to serial number labels and box labels. Changes to the Operator
Manual include editorial changes intended to clarify and/or correct some existing text, which
included updating the Company and instrument name and branding.
P970021/S036
9/23/11
Real-Time
GYNECARE THERMA-CHOICE™ III Uterine Balloon Therapy (UBT) SystemEthicon, Inc. – Women’s Health and Urology
Somerville, NJ
08876
Approval for a change in the material used to form the insulation layer of the thermocouple wires used within the balloon of the THERMACHOICE Uterine Balloon Therapy System.
P970051/S073
9/27/11
135-Day
Nucleus Cochlear Implant SystemCochlear Americas
Centennial, CO
80111
Approval for widening the acceptance window for the Input Frequency manufacturing test for the Nucleus Freedom BTE Speech Processor.
P980007/S022
9/13/11
Special
AxSYM Free PSA and ARCHITECT Free PSAAbbott Laboratories
Abbott Park, IL
60064
Approval for addition of a BSA screening test to identify protease contamination in vendor lots of incoming BSA prior to purchase.
P990012/S009
9/23/11
180-Day
Elecsys HBsAg Immunoassay,
Elecsys HBsAg Confirmatory, and Precicontrol HBsAg
Roche Diagnostics Corporation
Indianapolis, IN
46250
Approval for a manufacturing site located at Roche Diagnostics GmbH in Mannheim, Germany.
P990020/S034
9/13/11
180-Day
AneuRx Stent Graft SystemMedtronic Vascular
Santa Rosa, CA
95403
Approval for labeling modifications to incorporate information from completed clinical studies.
P990056/S013
9/23/11
180-Day
Elecsy total PSA ImmunoassayRoche Diagnostics
Indianapolis, IN
46250
Approval for a manufacturing site located at Roche Diagnostics GmbH in Mannheim, Germany.
P990081/S010
9/6/11
180-Day
PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary AntibodyVentana Medical Systems, Inc.
Tucson, AZ
85755
 
Approval for the PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody assay migration to the BenchMark ULTRA auto stainer, changes to PATHWAY HER-24 in 1 Control Slides, and Minor Software Updates (VSS 11.7 to 11.8).
P990081/S011
9/27/11
180-Day
PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary AntibodyVentana Medical Systems, Inc.
Tucson, AZ
85755
 
Approval for the addition of a strainer type barrier to the current DAB dispenser retainer design, colorization of stop barrel, and assembly equipment updates to accommodate the modified retainer.
P000008/S019
9/16/11
180-Day
LAP-BAND Adjustable Gastric Banding (LAGB) SystemAllergan, Inc.
Goleta, CA
93117
Approval of the post-approval study protocol.
P000009/S046
9/30/11
180-Day
Renamic Programmer and SoftwareBiotronik, Inc.
Lake Oswego, OR
97035
Approval for the Renamic Programmer and Software Version PSW 1101.U.
P000012/S034
9/29/11
Special
COBAS AmpliPrep/ COBAS AMPLICOR HCV TestRoche Molecular Systems, Inc.
Pleasanton, CA
94588
Approval for the revision of the Package Insert for the COBAS AmpiPrep/COBAS AMPLICOR HCV Test, v2.0.
P000025/S053
9/15/11
135-Day
MED-EL COMBI 40+ Cochlear Implant SystemMED-EL Corporation
Durham, NC
27713
Approval for the addition of a new implant cleaning system for cleaning cochlear components.
P000027/S011
9/23/11
180-Day
Elecsys free PSA ImmunoassayRoche Diagnostics
Indianapolis, IN
46250
Approval for a manufacturing site located at Roche Diagnostics GmbH in Mannheim, Germany.
P010012/S270
9/27/11
180-Day
Cardiac Resynchronization Therapy Defibrillator
(CRT-D)
Boston Scientific Corporation
St. Paul, MN
55112
Approval for post- approval study protocol.
P010019/S021
9/9/11
180-Day
CIBA VISION® AIR OPTIX® AQUA (lotrafilcon B) Extended Wear Soft Contact LensCIBA VISION Corporation
Duluth, GA
30097
Approval for a trade name change to the (lotrafilcon B) soft contact lenses with wetting agent in package saline. The device, as modified, will be marketed under the trade name CIBA VISION® AIR OPTIX® AQUA (lotrafilcon B) and is indicated for the following: CIBA VISION® AIR OPTIX® AQUA (lotrafilcon B)spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.
CIBA VISION® AIR OPTIX® AQUA (lotrafilcon B)toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to 6.00 diopters (D) or less of astigmatism. CIBA VISION® AIR OPTIX® AQUA (lotrafilcon B) multifocal soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters of astigmatism. CIBA VISION® AIR OPTIX® AQUA (lotrafilcon B)multifocal toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyopia) in phakic or aphakic persons with non-diseased eyes. The lenses may be worn by persons who have 10.00 diopters (D) or less of refractive and/or corneal astigmatism. The lenses may be prescribed for daily wear or extended wear for up to 6 nights of continuous wear with removal for disposal, or cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.
P010021/S020
9/15/11
135-Day
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and VITROS Immunodiagnostic Products Anti-HCV CalibratorOrtho-Clinical Diagnostics, Inc.
Rochester, NY
14626
Approval for changes to improved method of antifoam 204 incorporation into Anti-HCV assay reagent.
P010032/S038
9/20/11
135-Day
Eon Mini IPG Neurostimulation SystemSt. Jude Medical
Plano, TX
75024
Approval to add an alternate supplier for the feed through assembly.
P010054/S014
9/23/11
180-Day
Elecsys Anti-HBs Immunoassay,
Elecsys Precicontrol Anti-HBs
Roche Diagnostics Corporation
Indianapolis, IN
46250
Approval for a manufacturing site located at Roche Diagnostics GmbH in Mannheim, Germany.
P020009/S072
9/23/2011
135-Day
Express 2 Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Approval to update the gel rating specification scale used for resin material acceptance.
P020055/S002
9/27/11
180-Day
PATHWAY anti-C-Kit (9.7) Primary AntibodyVentana Medical Systems, Inc.
Tucson, AZ
85755
 
Approval for the addition of a strainer type barrier to the current DAB dispenser retainer design, colorization of stop barrel, and assembly equipment updates to accommodate the modified retainer.
P030002/S024
9/8/11
Real-Time
Crystalens® Accommodating Intraocular LensBausch & Lomb, Inc.
Aliso Viejo, CA
92656
Approval to modify the labeling to include the addition of 0.25 diopter increments for the +17 to +27 power range for the Crystalens® Accommodating Intraocular Lens, Model AT52AO.
P030009/S058
9/7/11
Real-Time
Integrity Coronary Stent SystemMedtronic Vascular
Santa Rosa, CA
95403
Approval to modify the Maximum Stent Inner Diameter (MSID) for the medium vessel stent sizes (3.0 mm to
4.0 mm diameters) from 4.75 mm to
5.0 mm.
P030024/S016
9/27/11
135-Day
VITROS Immunodiagnostics Products Anti-HBc Reagent Pack and
VITROS Immunodiagnostics Products Anti-HBc Calibrator
Ortho-Clinical Diagnostics, Inc.
Rochester, NY
14626
Approval for scaling up of a conjugate manufacturing process from 10 mg to 96 mg.
P030026/S022
9/27/11
135-Day
VITROS Immunodiagnostics Products Anti-HBc IgM Reagent Pack
And VITROS Immunodiagnostics Products Anti-HBc IgM Calibrator
Ortho-Clinical Diagnostics, Inc.
Rochester, NY
14626
Approval for scaling up of a conjugate manufacturing process from 10 mg to 96 mg.
P030031/S031
9/23/11
180-Day
NaviStar and Celsius ThermoCool Catheters for the Treatment of Drug Refractory Symptomatic Paroxysmal Atrial FibrillationBiosense Webster, Inc.
Diamond Bar, CA
91765
Approval of the post-approval study protocol.
P030035/S087
9/8/11
Real-Time
Frontier, Frontier II, Anthem Family of CRT-PsSt. Jude Medical
Sylmar, CA
91342
Approval for Model 3330 version 13.1 programmer software which includes enhancements to the layout/design of the existing Merlin PCS printed reports.
P030035/S088
9/28/11
Real-Time
Merlin Patient Care SystemSt. Jude Medical
Sylmar, CA
91342
Approval for the Model 3330 Version 12.1.10 Software for the Model 3650 Merlin Patient Care System.
P030054/S190
9/20/11
135-Day
Epic HF Family of CRT-DsSt. Jude Medical, Inc.
Sylmar, CA
91342
Approval for an alternate supplier of a circuit component.
P030054/S197
9/8/11
Real-Time
Unify CRT-DSt. Jude Medical, Inc.
Sunnyvale, CA
94086
Approval for changes to the controller integrated circuits for the devices.
P030054/S198
9/8/11
Real-Time
Epic HF, Atlas+ HF, Promote Family of CRT-DsSt. Jude Medical
Sylmar, CA
91342
Approval for Model 3330 version 13.1 programmer software which includes enhancements to the layout/design of the existing Merlin PCS printed reports.
P030054/S199
9/28/11
Real-Time
Merlin Patient Care SystemSt. Jude Medical
Sylmar, CA
91342
Approval for the Model 3330 Version 12.1.10 Software for the Model 3650 Merlin Patient Care System.
P040016/S069
9/23/11
135-Day
VeriFLEX (Liberté) Bare Metal Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Approval to update the gel rating specification scale used for resin material acceptance.
P050010/S011
9/16/11
135-Day
ProDisc-L Total Disc ReplacementSynthes Spine
West Chester, PA
19380
Approval for a change to a new calibration software program.
P050012/S035
9/2/11
135-Day
Dexcom™ Seven Plus® Continuous Glucose Monitoring SystemsDexcom, Inc.
San Diego, CA
92121
Approval for a proposed change to replace the paste in the surface mount technology (SMT) component soldering process for the transmitter component of the device.
P050012/S041
9/30/11
135-Day
 
Dexcom™ Seven and Seven Plus® Continuous Glucose Monitoring SystemsDexcom, Inc.
San Diego, CA
92121
Approval for a manufacturing change to implement a new spray fixture in Dexcom’s sensor membrane spray system.
P050023/S046
9/30/11
180-Day
Renamic Programmer and SoftwareBiotronik, Inc.
Lake Oswego, OR
97035
Approval for the Renamic Programmer and Software Version PSW 1101.U.
P050028/S021
9/30/11
Special
COBAS® TaqMan® HBV Test for use with The High Pure System and COBAS® AmpliPrep/
COBAS® TaqMan® HBV Test, v2.0
Roche Molecular Systems, Inc.
Pleasanton, CA
94588
Approval for the revisions of the Package Insert for the device.
P050033/S012
9/2/11
135-Day
Hydrelle, Dermal FillerAnika Therapeutics, Inc.
Bedford, MA
01730
Approval for proposed manufacture of small scale batches.
P050047/S019
9/23/11
Real-Time
Juvéderm Ultra XC and Juvéderm Ultra Plus XCAllergan
Goleta, CA
93117
Approval for an extension of the shelf life from 12 months to 24 months for the 0.8mL syringe (0.4mL and 0.8mL volumes); an increase in the
Monoethylglycinex-ylidide (MEGX) impurity specification from
≤ 0.3% w/w of label strength to ≤ 2.0% w/w of label strength; and an increase in total impurities specification from
≤ 0.5% w/w
of label strength to
≤ 2.5% w/w of la bel strength.
P060006/S019
9/23/11
135-Day
Express SD Renal Monorail Premounted Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Approval to update the gel rating specification scale used for resin material acceptance.
P060008/S066
9/23/11
135-Day
TAXUS Liberté Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Approval to update the gel rating specification scale used for resin material acceptance.
P060033/S067
9/30/11
Real-Time
Endeavor Sprint Zotarolimus-Eluting Coronary Stent SystemsMedtronic Vascular
Santa Rosa, CA
95403
Approval for a shelf life extension from two years to three years for the device.
P070008/S026
9/30/11
180-Day
Renamic Programmer and SoftwareBiotronik, Inc.
Lake Oswego, OR
97035
Approval for the Renamic Programmer and Software Version PSW 1101.U.
P070014/S022
9/16/11
180-Day
Bard LifeStent SOLO Vascular Stent SystemBard Peripheral Vascular, Inc.
Tempe, AZ
85281
Approval for the addition of a
200 mm length stent and a new delivery system. The device, as modified, will be marketed under the trade name Bard LifeStent SOLO Vascular Stent System and is intended to improve luminal diameter in the treatment of symptomatic denovo or restenotic lesions up to 240 mm in length in native Superficial Femoral Artery (SFA)
and/or proximal popliteal arteries with reference vessel diameters ranging from 4.0 - 6.5 mm.
P070022/S014
9/6/11
135-Day
Adiana Permanent Contraception SystemHologic, Inc.
Marlborough, MA
01752
Approval for minor changes to the sugar mold manufacturing process.
P070026/S003
9/16/11
Real-time
DePuy Ceramax® Ceramic Total Hip SystemDePuy Orthopaedics, Inc.
Warsaw, IN
46581
Approval for the addition of the Trio-Lock® BPS (Bone Preserving
Hip Stem) and
28 mm ceramic femoral heads with a 12/14 taper and +1.5 mm, +5 mm, and 8.5 mm offset as compatible modular components to the system, and minor labeling changes to
the device package insert and surgical technique. The device, as modified, will be marketed
under the trade name DePuy Ceramax® Ceramic Total Hip System and is indicated for
noncemented use in skeletally mature individuals undergoing primary total hip replacement
surgery for rehabilitation of hips damaged as a result of noninflammatory degenerative joint
disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, and post traumatic arthritis.
P080002/S001
9/23/11
180-Day
FC2 Female CondomThe Female Health Company
Chicago, IL
60654
Approval to change the shelf life of the FC2 Female Condom from three years to four years.
P080007/S005
9/2/11
135-Day
Bard®
E-LUMINEXX®
Vascular Stent
Bard Peripheral Vascular, Inc.
Tempe, AZ
85281
Approval for two changes to the validated EtO sterilization cycle (#14) chamber pressure parameters, for the device.
P080013/S004
9/29/11
180-Day
DuraSeal® Spine Sealant SystemCovidien
Bedford, MA
01730
Approval for a manufacturing site located at Covidien, LP in North Haven, Connecticut.
P080025/S020
9/6/11
Real-Time
Medtronic InterStim® Therapy SystemMedtronic Neuromodulation
Minneapolis, MN
55432
Approval for minor design, manufacturing, and labeling changes to the Model 3625 External Test Stimulator in order to establish compliance with functional requirements in the harmonized standards IEC (International Electrotechnical Commission) 60601-1 and IEC 60601-1-2.
P090007/S003
9/23/11
180-Day
Elecsys Anti-HCV Immunoassay,
Elecsys Precicontrol Anti-HCV for use on Cobas e411
Roche Diagnostics Corporation
Indianapolis, IN
46250
Approval for a manufacturing site located at Roche Diagnostics GmbH in Mannheim, Germany.
P090008/S003
9/23/11
180-Day
Elecsys Anti-HCV Immunoassay,
Elecsys Precicontrol Anti-HCV for use on Cobas e601
Roche Diagnostics Corporation
Indianapolis, IN
46250
Approval for a manufacturing site located at Roche Diagnostics GmbH in Mannheim, Germany.
P090009/S003
9/23/11
180-Day
Elecsys Anti-HCV Immunoassay,
Elecsys Precicontrol Anti-HCV for use on e170 Immunoassay Analyzer
Roche Diagnostics Corporation
Indianapolis, IN
46250
Approval for a manufacturing site located at Roche Diagnostics GmbH in Mannheim, Germany.
P090018/S010
9/23/11
180-Day
Esteem Totally Implantable Hearing SystemEnvoy Medical, Inc.
Saint Paul, MN
55110
Approval of the post-approval study protocol.
P090022/S005
9/22/11
Real-Time
Softec HD Posterior Chamber Intraocular Lens (IOL)Lenstec, Inc.
St. Petersburg, FL
33716
Approval to amend the approved labeling to allow for the use of the ASICO Softip injection system, Model number
AS-9300 with the Softec HD, Softec I and Softec HD PS Intraocular Lenses (IOLs).
P100021/S010
9/16/11
Special
Endurant Stent Graft SystemMedtronic Vascular Santa Rosa, CA
95403
Approval for minor labeling changes to update caution statements.
P100029/S002
9/26/11
135-Day
St. Jude Trifecta Heart ValveSt. Jude Medical
St. Paul, MN
55117
Approval for an increase in the maximum exposure time of liquid sterilant.
P100031/S003
9/23/11
180-Day
Elecsys Anti-HBc Immunoassay on the MODULAR ANALYTICS E170 Immunoassay AnalyzerRoche Diagnostics Corporation
Indianapolis, IN
46250
Approval for a manufacturing site located at Roche Diagnostics GmbH in Mannheim, Germany.
P100032/S003
9/23/11
180-Day
Elecsys Anti-HBc Immunoassay on the Elecsys 2010 Immunoassay AnalyzerRoche Diagnostics Corporation
Indianapolis, IN
46250
Approval for a manufacturing site located at Roche Diagnostics GmbH in Mannheim, Germany.
P100040/S005
9/14/11
180-Day
The Valiant Thoracic Stent Graft with Captivia Delivery SystemMedtronic Vascular
Santa Rosa, CA
95403
Approval of the post-approval study protocol.

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

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
N12159/S028
9/15/11
Surgicel Absorbable HemostatEthicon, Inc.
Somerville, NJ
08876
Addition of new packaging equipment.
N17600/S025
9/29/11
Avitene Microfibrillar Collagen Hemostasis (MCH) ProductsDavol, Inc.
Warwick, RI
02886
Changes to quality control testing for incoming raw material (bovine corium) and modification to finished goods testing.
N18033/S060
9/14/11
VISTAKON (etafilcon A) Brand Contact LensesVision Care, Inc.
Jacksonville, FL
32256
Change to the Flow and Temperature Monitoring System for Injection Molding.
P790002/S027
9/7/11
EBI Bone Healing SystemEBI, LLC
Parsippany, NJ
07054
Replacement of an analog electrical isolation tester with a digital electronic isolation tester, and addition of a manual hand-soldering process as an alternative to the existing automatic soldering process.
P790007/S031
9/14/11
Hancock I Low Porosity and Modified Orifice Valve ConduitMedtronic, Inc.
Santa Ana, CA
92705
Addition of a new tissue supplier.
P800002/S017
9/29/11
Avitene Microfibrillar Collagen Hemostasis (MCH) ProductsDavol, Inc.
Warwick, RI
02886
Changes to quality control testing for incoming raw material (bovine corium) and modification to finished goods testing.
P820003/S111
9/7/11
Patient CableMedtronic, Inc.
Mounds View, MN
55112
Changes to the patient cable proximal connector, and the solder and reflux manufacturing materials.
P820003/S112
9/16/11
External Pulse Generators and AnalyzerMedtronic, Inc.
Mounds View, MN
55112
Change from manual to automated process at a supplier location.
P860003/S061
9/22/11
CELLEX Procedure Kit used with the Therakos CELLEX Photopheresis SystemTHERAKOS, Inc.
Raritan, NJ
08869
Molding process change for a component of the CELLEX procedure kit.
P900056/S109
9/15/11
Rotablator Rotational Atherectomy SystemBoston Scientific Corporation
Maple Grove, MN
55311
Alternate supplier of coating material for the Rotablator Console.
P900060/S046
9/2/11
Carbomedics Prosthetic Heart ValveSorin Group USA, Inc.
Arvada, CO
80004
Change in the tumbling equipment and the corresponding tumbling process.
P910077/S117
9/1/11
VENTAK PRx and VENTAK MINI Implantable Pulse Generator SystemBoston Scientific Corporation
St. Paul, MN
55112
Change to a contract manufacturer’s solder stencil and pick-and-place equipment.
P930014/S054
9/26/11
AcrySof and AcrySof ReSTOR Intraocular LensesAlcon Research, Ltd.
Fort Worth, TX
76134
Implement tighter temperature and relative humidity controls in the formulation process of the products.
P930014/S056
9/29/11
AcrySof Intraocular Lens and AcrySof ReSTOR Intraocular LensAlcon Research, Ltd.
Fort Worth, TX
76134
Addition of an 8-Cavity Fixed Wafer Mold M-5.
P930027/S012
9/7/11
PSA IMMULITE ASSAYSiemens Healthcare Diagnostics
Walpole, MA
02032
Change to implement use of a fully automated filling and packaging line for the IMMULITE chemiluminescent Substrate. The current method of filling and packaging the Substrate is by use of a semi-automated line. Full automation of the line eliminates repetitive actions that are performed manually.”
P930027/S013
9/12/11
IMMULITE/
IMMULITE 1000 PSA, IMMULITE 2000 PSA, IMMULITE/ IMMULITE 1000 Third Generation PSA and IMMULITE 2000 Third Generation PSA
Siemens Healthcare Diagnostics, Inc.
East Walpole, MA
02032
Permanent implementation of the incoming specification for Zinc content for 2-amino-2-methyl-1- propanol (AMP) buffer and elimination of substrate verification testing.
P930039/S062
9/7/11
CapSureFixMedtronic, Inc.
Mounds View, MN
55112
Replacement of a laser welder and process parameter updates.
P950024/S036
9/21/11
CapSure Epi Epicardial Pacing LeadsMedtronic, Inc.
Mounds View, MN
55112
New process settings established for a blister sealer machine.
P950029/S062
9/1/11
Reply SR/DR and Esprit SR/DR IPGSorin CRM, Inc.
Plymouth, MN
55441
Modify the pre-conditioning cycle before laser welding and the use of an alternate laser source.
P960040/S245
9/15/11
COGNIS CRT-DBoston Scientific Corporation
St. Paul, MN
55112
Alternate suppliers for ceramic capacitors.
P970003/S134
9/9/11
VNS Therapy SystemCyberonics, Inc.
Houston, TX
77058
Additional spot welding machine.
D970012/S088
9/20/11
AMS Model 700 Inflatable Penile ProsthesisAmerican Medical Systems
Minnetonka, MN
55343
New software-based monitoring system for a manufacturing process.
P970020/S067
9/1/11
Multi-Link ZETA Coronary Stent SystemAbbott Vascular, Inc.
Temecula, CA
92591
Implementation of an automated system for process monitoring.
P970020/S068
9/27/11
Multi-Link Zeta Coronary Stent SystemAbbott Vascular, Inc.
Temecula, CA
92591
Modification in the cutting process of a component.
P970031/S035
9/14/11
Freestyle Aortic Root BioprosthesisMedtronic, Inc.
Santa Ana, CA
92705
Addition of a new tissue supplier.
P980016/S319
9/29/11
Protecta and Protecta XTMedtronic, Inc.
Mounds View, MN
55112
Changes to hybrid acceptance testing.
P980018/S014
9/9/11
HercepTest™Dako Denmark A/S
Denmark
Automated manufacturing process of control cells for the Control Slides.
P980022/S098
9/22/11
Paradigm REAL-TIME SystemMedtronic MiniMed Northridge, CA
91325
Component manufacturing location change for the supplier of the vibrator motor used in the manufacture of the Paradigm REAL-TIME Pump and the Paradigm REAL-TIME Revel Pump.
P980035/S240
9/22/11
Adapta, Relia, Sensia and Versa Families of Implantable Pulse GeneratorsMedtronic, Inc.
Mounds View, MN
55112
Process adjustments for Titanium and oxide layer thicknesses.
P980043/S033
9/14/11
Hancock II Porcine BioprosthesisMedtronic, Inc.
Santa Ana, CA
92705
Addition of a new tissue supplier.
P990043/S014
9/16/11
ETI-EBK PLUS KitDiaSorin, Inc.
Stillwater, MN
55082
Use of an additional vendor of Chromogen/
Substrate bulk solution to manufacture the final Chromogen/
Substrate reagent for the ETI-EBK PLUS Kit. The stability
data for the new vendor's Chromogen/ Substrate reagent using the approved protocol supports an
expiration date of 16 months.
P990064/S040
9/14/11
Mosaic Porcine BioprosthesisMedtronic, Inc.
Santa Ana, CA
92705
Addition of a new tissue supplier.
P000006/S026
9/26/11
Titan Inflatable Penile ProsthesisColoplast Corporation
Minneapolis, MN
55411
Addition of a new piece of automatic equipment in the manufacturing process.
P000025/S055
9/2/11
COMBI 40+ Cochlear Implant SystemMED-EL Corporation
Durham, NC
27713
Additional supplier for the sterile barrier system.
P000025/S056
9/23/11
COMBI 40+ Cochlear Implant SystemMED-EL Corporation
Durham, NC
27713
Change in equipment used for the production of the electrode wires of all cochlear implants.
P000029/S070
9/9/11
Deflux Injectable GelSchiff & Company
West Caldwell, NJ
07006
Change in composition of the biological indicator.
P000044/S027
9/16/11
VITROS Immunodiagnostic Products HBsAg Reagent Pack and CalibratorOrtho-Clinical Diagnostics
Rochester, NY
14626
Conversion of the in process limit from a signal ratio to a test result.
P000053/S038
9/20/11
AMS 800 Artificial Urinary SphincterAmerican Medical Systems
Minnetonka, MN
55343
New software-based monitoring system for a manufacturing process.
P010007/S006
9/7/11
AFP IMMULITE ASSAYSiemens Healthcare Diagnostics, Inc.
Walpole, MA
02032
Change to implement use of a fully automated filling and packaging line for the IMMULITE chemiluminescent Substrate. The current method of filling and packaging the Substrate is by use of a semi-automated line. Full automation of the line eliminates repetitive actions that are performed manually.”
P010007/S007
9/12/11
IMMULITE/
IMMULITE 1000 AFP and IMMULITE 2000/IMMULITE 2500 AFP
Siemens Healthcare Diagnostics, Inc.
East Walpole, MA
02032
Permanent implementation of the incoming specification for Zinc content for 2-amino-2-methyl-1- propanol (AMP) buffer and elimination of substrate verification testing.
P010012/S271
9/15/11
TELIGEN ICDBoston Scientific Corporation
St. Paul, MN
55112
Alternate suppliers for ceramic capacitors.
P010031/S273
9/29/11
Protecta and Protecta XTMedtronic, Inc.
Mounds View, MN
55112
Changes to hybrid acceptance testing.
P010050/S013
9/2/11
Immulite® HBsAgSiemens Healthcare Diagnostics, Inc.
East Walpole, MA
02032
Full automation of the filling and packaging line for the I mmulite Chemiluminescent Substrate Reagent, accessory used with all the Immulite Assays.
P010050/S014
9/13/11
IMMULITE/ IMMULITE 1000 and IMMULITE 2000 HBsAg and 2000 HBsAg ConfirmatorySiemens Healthcare Diagnostics, Inc.
East Walpole, MA 02032
Implementation of an incoming specification for zinc content for 2-amino-2-methyl-1- propanol (AMP) buffer and elimination of substrate verification testing.
P010051/S009
9/2/11
Immulite® Anti-HBcSiemens Healthcare Diagnostics, Inc.
East Walpole, MA
02032
Full automation of the filling and packaging line for the Immulite Chemiluminescent Substrate Reagent, accessory used with all the Immulite Assays.
P010051/S010
9/13/11
IMMULITE/ IMMULITE 1000 and IMMULITE 2000 Anti-HBcSiemens Healthcare Diagnostics, Inc.
East Walpole, MA 02032
Implementation of an incoming specification for zinc content for 2-amino-2-methyl-1- propanol (AMP) buffer and elimination of substrate verification testing.
P010052/S009
9/2/11
Immulite® Anti-HBsSiemens Healthcare Diagnostics, Inc.
East Walpole, MA
02032
Full automation of the filling and packaging line for the Immulite Chemiluminescent Substrate Reagent, accessory used with all the Immulite Assays.
P010052/S010
9/13/11
IMMULITE/ IMMULITE 1000 and IMMULITE 2000 Anti-HBsSiemens Healthcare Diagnostics, Inc.
East Walpole, MA 02032
Implementation of an incoming specification for zinc content for 2-amino-2-methyl-1- propanol (AMP) buffer and elimination of substrate verification testing.
P010053/S008
9/2/11
Immulite® Anti-HBc IgMSiemens Healthcare Diagnostics
East Walpole, MA
02032
Full automation of the filling and packaging line for the Immulite Chemiluminescent Substrate Reagent, accessory used with all the Immulite Assays.
P010053/S009
9/13/11
IMMULITE/ IMMULITE 1000 and IMMULITE 2000 Anti-HBc IgMSiemens Healthcare Diagnostics, Inc.
East Walpole, MA 02032
Implementation of an incoming specification for zinc content for 2-amino-2-methyl-1- propanol (AMP) buffer and elimination of substrate verification testing.
P020009/S077
9/27/11
Express 2 OTW Coronary Stent System (CSS)Boston Scientific Corporation
Maple Grove, MN
55311
Changes to process methods and software supporting the Plasma Treater and the Hydrophilic Coating (HPC) equipment.
P020045/S039
9/15/11
Freezor, Freezor Xtra Surgical, Freezor MAX SurgicalMedtronic CryoCath LP
Quebec, Canada
H9R 5Z8
Various changes including the addition of a new micrometer and new equipment for resistance and continuity testing.
P020047/S038
9/1/11
Multi-Link Vision and Multi-Link Mini Vision OTW and RX Coronary Stent SystemsAbbott Vascular, Inc.
Temecula, CA
92591
Implementation of an automated system for process monitoring.
P020047/S039
9/27/11
Multi-Link Vision and Multi-Link Mini Vision OTW and RX Coronary Stent SystemsAbbott Vascular, Inc.
Temecula, CA
92591
Modification in the cutting process of a component.
P030002/S025
9/15/11
Crystalens Accommodating Intraocular LensBausch & Lomb, Inc.
Aliso Viejo, CA
92656
Refurbishment of an autoclave sterilizer.
P040002/S033
9/29/11
AFX Accessory Stent Graft Delivery SystemsEndologix, Inc.
Irvine, CA
92618
Automation of a loading process.
P040012/S041
9/1/11
RX Acculink Self- Expanding Stent SystemAbbott Vascular, Inc.
Temecula, CA
92591
Implementation of an automated system for process monitoring.
P040016/S076
9/27/11
VeriFLEX (Formerly Liberté) OTW Bare Metal CSSBoston Scientific Corporation
Maple Grove, MN
55311
Changes to process methods and software supporting the Plasma Treater and the Hydrophilic Coating (HPC) equipment.
P040020/S035
9/26/11
AcrySof and AcrySof ReSTOR Intraocular LensesAlcon Research, Ltd.
Fort Worth, TX
76134
Implement tighter temperature and relative humidity controls in the formulation process of the products.
P040020/S037
9/29/11
AcrySof Intraocular Lens and AcrySof ReSTOR Intraocular LensAlcon Research, Ltd.
Fort Worth, TX
76134
Addition of an 8-Cavity Fixed Wafer Mold M-5.
P040037/S037
9/16/11
Gore VIABAHN EndoprosthesisW.L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Replacement of the in-house burst tester for the base tube component.
P040038/S022
9/1/11
XACT Carotid Stent SystemAbbott Vascular, Inc.
Temecula, CA
92591
Implementation of an automated system for process monitoring.
P040038/S023
9/2/11
XACT Carotid Stent SystemAbbott Vascular, Inc.
Temecula, CA
92591
Change of supplier and manufacturing process for a component in the handle of the delivery system.
P060002/S020
9/22/11
Bard Flair Endovascular Stent GraftC.R. Bard, Inc.
Tempe, AZ
85281
Use of a new mold made from a different material for manufacture of a critical device component.
P060005/S005
9/7/11
FPSA IMMULITE ASSAYSiemens Healthcare Diagnostics
Walpole, MA
02032
Change to implement use of a fully automated filling and packaging line for the IMMULITE chemiluminescent Substrate. The current method of filling and packaging the Substrate is by use of a semi-automated line. Full automation of the line eliminates repetitive actions that are performed manually.”
P060005/S006
9/12/11
IMMULITE/
IMMULITE 1000 free PSA and IMMULITE 2000 free PSA
Siemens Healthcare Diagnostics, Inc.
East Walpole, MA
02032
Permanent implementation of the incoming specification for Zinc content for 2-amino-2-methyl-1- propanol (AMP) buffer and elimination of substrate verification testing.
P060008/S075
9/27/11
TAXUS Liberté OTW Paclitaxel-Eluting CSSBoston Scientific Corporation
Maple Grove, MN
55311
Changes to process methods and software supporting the Plasma Treater and the Hydrophilic Coating (HPC) equipment.
P060030/S022
9/22/11
COBAS AmpliPrep/ COBAS TaqMan HCV TestRoche Molecular Systems, Inc.
Pleasanton, CA
94588
Revision of the in-process testing assay validation criteria for the Positive Control bulk materials used for the device.
P070015/S079
9/1/11
XIENCE V and PROMUS Everolimus-Eluting Coronary Stent SystemAbbott Vascular, Inc.
Temecula, CA
92591
Implementation of an automated system for process monitoring.
P070015/S080
9/27/11
XIENCE V and PROMUS Everolimus-Eluting Coronary Stent SystemAbbott Vascular, Inc.
Temecula, CA
92591
Modification in the cutting process of a component.
P070027/S031
9/7/11
Talent Endoluminal Occluder SystemMedtronic Vascular
Santa Rosa, CA
95403
Change to the firm’s sterilization process.
P090006/S007
9/7/11
Complete SE Vascular Stent SystemMedtronic Vascular
Santa Rosa, CA
95403
Reduction in pyrogen testing sample size.
P090013/S037
9/1/11
Revo MRIMedtronic, Inc.
Mounds View, MN
55112
Elimination of a burn-in process for some electrical components.
P090013/S038
9/7/11
CapSureFixMedtronic, Inc.
Mounds View, MN
55112
Replacement of a laser welder and process parameter updates.
P090018/S012
9/21/11
EsteemEnvoy Medical Corporation
Saint Paul, MN
55110
New bone screw supplier and a change in the steam sterilization process.
P090022/S008
9/28/11
Softec HD, Softec I, and Softec HD PS Intraocular Lenses (IOL)Lenstec, Inc.
Saint Petersburg, FL
33716
Removal of two manufacturing process steps in order to make the IOL manufacturing process more efficient.
P100010/S011
9/15/11
Freezor MAXMedtronic CryoCath LP
Quebec, Canada
H9R 5Z8
Various changes including the addition of a new micrometer and new equipment for resistance and continuity testing.
P100013/S002
9/27/11
Exoseal Vascular Closure DeviceCordis Corporation
Bridgewater, NJ
08807
Several manufacturing changes at two different suppliers.
P100014/S003
9/9/11
Solesta Injectable GelSchiff & Company
West Caldwell, NJ
07006
Change in composition of the biological indicator.
P100023/S016
9/7/11
Ion Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Change to the firm’s delivery catheter bonding process.
P100023/S017
9/27/11
ION (Taxus Element) Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Update of software to existing process equipment and modification of corresponding process steps.
P100023/S018
9/27/11
ION (TAXUS Element) Paclitaxel-Eluting CSSBoston Scientific Corporation
Maple Grove, MN
55311
Changes to process methods and software supporting the Plasma Treater and the Hydrophilic Coating (HPC) equipment.
P100029/S007
9/7/11
Trifecta Heart ValveSt. Jude Medical, Inc.
St. Paul, MN
55117
Addition of an alternate vendor for stent tubing material.
P110001/S001
9/21/11
RX Herculink Elite Renal and Biliary Stent SystemAbbott Vascular
Temecula, CA
92591
Changes to the solution manufacturing process.

Summary of PMA Originals & Supplements Approved
Originals: 1
Supplements: 81

Summary of PMA Originals Under Review
Total Under Review: 94
Total Active: 47
Total On Hold: 47
Number Greater Than 180 Days: 3

Summary of PMA Supplements Under Review
Total Under Review: 585
Total Active: 430
Total On Hold: 155
Number Greater Than 180 Days: 11

Summary of All PMA Submissions Received
Originals: 2
Supplements: 69

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 81
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time):118.4
FDA Time: 94.0 Days MFR Time: 24.4 Days