The Food & Drug Administration released a list of pre-market approvals granted in September:
PMA Original Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE 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 APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P830060/S067
9/1/11 Real-Time |
Reliance 4-Site Leads and Accessories | Boston 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 Wireform | Edwards Lifesciences, LLC
Irvine, CA 92614 |
Approval for new eddy current test equipment. |
| P880006/S073
9/8/11 Real-Time |
Sensolog/Dialog/ Regency Family of Pacemakers | St. 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 System | St. 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 Pacemakers | St. 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 System | St. 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 PSA | Abbott 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 ICDs | St. Jude Medical, Inc.
Sylmar, CA 91342 |
Approval for an alternate supplier of a circuit component. |
| P910023/S271
9/8/11 Real-Time |
Fortify ICD | St. 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 ICDs | St. 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 System | St. 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 Accessories | Boston 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 Balloon | Boston 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 Software | Biotronik, 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 Systems | Abbott 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 System | Advanced 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 Pacemakers | St. 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 System | St. 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) System | Ethicon, 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 System | Cochlear 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 PSA | Abbott 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 System | Medtronic 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 Immunoassay | Roche 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 Antibody | Ventana 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 Antibody | Ventana 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) System | Allergan, Inc.
Goleta, CA 93117 |
Approval of the post-approval study protocol. |
| P000009/S046
9/30/11 180-Day |
Renamic Programmer and Software | Biotronik, 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 Test | Roche 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 System | MED-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 Immunoassay | Roche 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 Lens | CIBA 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 Calibrator | Ortho-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 System | St. 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 System | Boston 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 Antibody | Ventana 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 Lens | Bausch & 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 System | Medtronic 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 Fibrillation | Biosense 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-Ps | St. 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 System | St. 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-Ds | St. Jude Medical, Inc.
Sylmar, CA 91342 |
Approval for an alternate supplier of a circuit component. |
| P030054/S197
9/8/11 Real-Time |
Unify CRT-D | St. 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-Ds | St. 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 System | St. 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 System | Boston 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 Replacement | Synthes 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 Systems | Dexcom, 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 Systems | Dexcom, 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 Software | Biotronik, 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 Filler | Anika 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 XC | Allergan
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 System | Boston 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 System | Boston 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 Systems | Medtronic 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 Software | Biotronik, 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 System | Bard 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 System | Hologic, 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 System | DePuy 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 Condom | The 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 System | Covidien
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 System | Medtronic 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 System | Envoy 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 System | Medtronic 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 Valve | St. 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 Analyzer | Roche 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 Analyzer | Roche 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 System | Medtronic 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 APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| N12159/S028
9/15/11 |
Surgicel Absorbable Hemostat | Ethicon, Inc.
Somerville, NJ 08876 |
Addition of new packaging equipment. |
| N17600/S025
9/29/11 |
Avitene Microfibrillar Collagen Hemostasis (MCH) Products | Davol, 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 Lenses | Vision Care, Inc.
Jacksonville, FL 32256 |
Change to the Flow and Temperature Monitoring System for Injection Molding. |
| P790002/S027
9/7/11 |
EBI Bone Healing System | EBI, 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 Conduit | Medtronic, Inc.
Santa Ana, CA 92705 |
Addition of a new tissue supplier. |
| P800002/S017
9/29/11 |
Avitene Microfibrillar Collagen Hemostasis (MCH) Products | Davol, 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 Cable | Medtronic, 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 Analyzer | Medtronic, 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 System | THERAKOS, Inc.
Raritan, NJ 08869 |
Molding process change for a component of the CELLEX procedure kit. |
| P900056/S109
9/15/11 |
Rotablator Rotational Atherectomy System | Boston Scientific Corporation
Maple Grove, MN 55311 |
Alternate supplier of coating material for the Rotablator Console. |
| P900060/S046
9/2/11 |
Carbomedics Prosthetic Heart Valve | Sorin 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 System | Boston 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 Lenses | Alcon 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 Lens | Alcon Research, Ltd.
Fort Worth, TX 76134 |
Addition of an 8-Cavity Fixed Wafer Mold M-5. |
| P930027/S012
9/7/11 |
PSA IMMULITE ASSAY | Siemens 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 |
CapSureFix | Medtronic, Inc.
Mounds View, MN 55112 |
Replacement of a laser welder and process parameter updates. |
| P950024/S036
9/21/11 |
CapSure Epi Epicardial Pacing Leads | Medtronic, 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 IPG | Sorin 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-D | Boston Scientific Corporation
St. Paul, MN 55112 |
Alternate suppliers for ceramic capacitors. |
| P970003/S134
9/9/11 |
VNS Therapy System | Cyberonics, Inc.
Houston, TX 77058 |
Additional spot welding machine. |
| D970012/S088
9/20/11 |
AMS Model 700 Inflatable Penile Prosthesis | American Medical Systems
Minnetonka, MN 55343 |
New software-based monitoring system for a manufacturing process. |
| P970020/S067
9/1/11 |
Multi-Link ZETA Coronary Stent System | Abbott Vascular, Inc.
Temecula, CA 92591 |
Implementation of an automated system for process monitoring. |
| P970020/S068
9/27/11 |
Multi-Link Zeta Coronary Stent System | Abbott Vascular, Inc.
Temecula, CA 92591 |
Modification in the cutting process of a component. |
| P970031/S035
9/14/11 |
Freestyle Aortic Root Bioprosthesis | Medtronic, Inc.
Santa Ana, CA 92705 |
Addition of a new tissue supplier. |
| P980016/S319
9/29/11 |
Protecta and Protecta XT | Medtronic, 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 System | Medtronic 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 Generators | Medtronic, Inc.
Mounds View, MN 55112 |
Process adjustments for Titanium and oxide layer thicknesses. |
| P980043/S033
9/14/11 |
Hancock II Porcine Bioprosthesis | Medtronic, Inc.
Santa Ana, CA 92705 |
Addition of a new tissue supplier. |
| P990043/S014
9/16/11 |
ETI-EBK PLUS Kit | DiaSorin, 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 Bioprosthesis | Medtronic, Inc.
Santa Ana, CA 92705 |
Addition of a new tissue supplier. |
| P000006/S026
9/26/11 |
Titan Inflatable Penile Prosthesis | Coloplast 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 System | MED-EL Corporation
Durham, NC 27713 |
Additional supplier for the sterile barrier system. |
| P000025/S056
9/23/11 |
COMBI 40+ Cochlear Implant System | MED-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 Gel | Schiff & Company
West Caldwell, NJ 07006 |
Change in composition of the biological indicator. |
| P000044/S027
9/16/11 |
VITROS Immunodiagnostic Products HBsAg Reagent Pack and Calibrator | Ortho-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 Sphincter | American Medical Systems
Minnetonka, MN 55343 |
New software-based monitoring system for a manufacturing process. |
| P010007/S006
9/7/11 |
AFP IMMULITE ASSAY | Siemens 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 ICD | Boston Scientific Corporation
St. Paul, MN 55112 |
Alternate suppliers for ceramic capacitors. |
| P010031/S273
9/29/11 |
Protecta and Protecta XT | Medtronic, Inc.
Mounds View, MN 55112 |
Changes to hybrid acceptance testing. |
| P010050/S013
9/2/11 |
Immulite® HBsAg | Siemens 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 Confirmatory | Siemens 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-HBc | Siemens 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-HBc | Siemens 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-HBs | Siemens 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-HBs | Siemens 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 IgM | Siemens 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 IgM | Siemens 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 Surgical | Medtronic 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 Systems | Abbott 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 Systems | Abbott Vascular, Inc.
Temecula, CA 92591 |
Modification in the cutting process of a component. |
| P030002/S025
9/15/11 |
Crystalens Accommodating Intraocular Lens | Bausch & Lomb, Inc.
Aliso Viejo, CA 92656 |
Refurbishment of an autoclave sterilizer. |
| P040002/S033
9/29/11 |
AFX Accessory Stent Graft Delivery Systems | Endologix, Inc.
Irvine, CA 92618 |
Automation of a loading process. |
| P040012/S041
9/1/11 |
RX Acculink Self- Expanding Stent System | Abbott Vascular, Inc.
Temecula, CA 92591 |
Implementation of an automated system for process monitoring. |
| P040016/S076
9/27/11 |
VeriFLEX (Formerly Liberté) OTW Bare Metal CSS | Boston 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 Lenses | Alcon 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 Lens | Alcon Research, Ltd.
Fort Worth, TX 76134 |
Addition of an 8-Cavity Fixed Wafer Mold M-5. |
| P040037/S037
9/16/11 |
Gore VIABAHN Endoprosthesis | W.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 System | Abbott Vascular, Inc.
Temecula, CA 92591 |
Implementation of an automated system for process monitoring. |
| P040038/S023
9/2/11 |
XACT Carotid Stent System | Abbott 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 Graft | C.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 ASSAY | Siemens 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 CSS | Boston 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 Test | Roche 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 System | Abbott 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 System | Abbott Vascular, Inc.
Temecula, CA 92591 |
Modification in the cutting process of a component. |
| P070027/S031
9/7/11 |
Talent Endoluminal Occluder System | Medtronic Vascular
Santa Rosa, CA 95403 |
Change to the firm’s sterilization process. |
| P090006/S007
9/7/11 |
Complete SE Vascular Stent System | Medtronic Vascular
Santa Rosa, CA 95403 |
Reduction in pyrogen testing sample size. |
| P090013/S037
9/1/11 |
Revo MRI | Medtronic, Inc.
Mounds View, MN 55112 |
Elimination of a burn-in process for some electrical components. |
| P090013/S038
9/7/11 |
CapSureFix | Medtronic, Inc.
Mounds View, MN 55112 |
Replacement of a laser welder and process parameter updates. |
| P090018/S012
9/21/11 |
Esteem | Envoy 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 MAX | Medtronic 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 Device | Cordis Corporation
Bridgewater, NJ 08807 |
Several manufacturing changes at two different suppliers. |
| P100014/S003
9/9/11 |
Solesta Injectable Gel | Schiff & Company
West Caldwell, NJ 07006 |
Change in composition of the biological indicator. |
| P100023/S016
9/7/11 |
Ion Paclitaxel-Eluting Coronary Stent System | Boston 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 System | Boston 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 CSS | Boston 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 Valve | St. 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 System | Abbott 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
