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PMA Final Decisions Rendered for October 1996 |
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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. Information about the PDF Reader is available.
| APPLICATION NUMBER/ DATE of APPROVAL |
DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP |
DEVICE DESCRIPTION/ INDICATIONS |
|---|---|---|---|
| P920031
10/2/96 |
(SYVA) EMIT® Cyclosporine Specific Assay | Behring Diagnostics, Inc.
San Jose, CA 95161 |
The device is indicated for in vitro diagnostic use on the Roche Diagnostics Systems COBAS MIRA, COBAS MIRA S, and COBAS MIRA Plus Chemistry Systems for the quantitative analysis of cyclosporine (CSA) in human whole blood as an aid in the management of cyclosporine therapy in kidney, heart, and liver transplant patients. |
| P950019
10/29/96 |
Ray Threaded Fusion Cage (TFC) | United States Surgical Corporation
Norwalk, CT 06856 |
Indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two levels from <2 to S1. |
| P950037
10/11/96 |
DROMOS DR/DR-A and DROMOS SR/SR-B Cardiac Pacing Systems | Biotronik, Inc.
Lake Oswego, OR 97035 |
Rate adaptive pacing with the DROMOS DR & DROMOS SR Pulse Generators are indicated for patients exhibiting chronotropic incompetence and who would benefit from increased pacing rates concurrent with physical activity. |
|
PMA Supplement Approvals |
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| APPLICATION NUMBER/ DATE of APPROVAL |
DEVICE TRADE NAME | COMPANY NAME CITY, STATE<& ZIP |
DEVICE DESCRIPTION/INDICATIONS |
| N17755/S045
10/17/96 |
Zimmer® Bone Cement Dough-Type, Zimmer® L.V.C. ® Low Viscosity Bone Cement and Osteobond Copolymer Bone Cement | Zimmer
Warsaw, IN 46581-0708 |
Change in ethylene oxide sterilization process used in the sterilization of the external surface of the bone cement's monomer ampules |
| N18033/S029
10/7/96 |
Acuvue® (Etafilcon A) Exteneded Wear Contact Lens (Clear and Tinted with UV Blocker) | Vistakon
Jacksonville, FL 32247 |
Addition of a UV Blocker, Norbloc® 7966, to the approved molded Etafilcon A Extended Wear Contact Lens (clear and with visibility tint), and a multi-focal design which was previously cleared for the Daily Wear Etafilcon A Lens under K953804. |
| P800025/S005
10/2/96 |
Quantitope 125I AFP Kit and Control Serum | Sanofi Diagnostics Pasteur, Inc.
Chaska, MN 55318 |
Replacement of the current radiolabeled AFP with a new AFP Antigen. |
| P810046/S165
10/25/96 |
ACS TX2000™ Coronary Dilation Catheter | Guidant Corporation
Santa Clara, CA 95052-8167 |
Indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. |
| P820018/S070
10/3/96 |
Reflex Models 8218 and 8220E; Reflex DDD Models 8223E and 8224; and Simplex Model 8232 Pulse Generators | Telectronics Pacing Systems, Inc.
Englewood, CO 80112 |
Approval for modifications to the labeling to include information regarding the use of cellular telephones with patients wearing these devices. |
| P820083/S023
10/3/96 |
Gore-Tex™ Suture | W.L. Gore & Assoc., Inc.
Flagstaff, AZ 86002-2300 |
Addition of two new indications: 1) for use in the repair of dura mater and 2) for use in the repair or replacement of chordae tendineae. |
| P820083/S024
10/3/96 |
Gore-Tex™ Suture | W.L. Gore & Assoc., Inc.
Flagstaff, AZ 86002-2300 |
Addition of two new indications: 1) for use in the repair of dura mater and 2) for use in the repair or replacement of chordae tendineae. |
| P830045/S051
10/9/96 |
Phoenix 2 and Paragon II Pacing Systems | Siemens-Pacesetter, Inc.
Sylmar, CA 91392-9221 |
Modification of labeling to include a "cellular tested" logo to the shelf package of the following pacemaker models: Phoenix 2 (2005/2008/2009), Paragon (2010/2011/2012), Paragon II (2016), Synchrony (2020), Synchrony II (2022/2023), Synchrony III (2028/2029), Solus (2002/2003), Solus II (2006/2007), Trilogy (2350/2308/2250). |
| P830055/S048
10/11/96 |
New Jersey LCS® Total Knee System | Depuy, Inc.
Warsaw, IN 46581-0988 |
Packaging change from a blister pack with Tyvek Lid to a Chevron Peel Pouch for textured and porous patella components of the device. |
| P830055/S049
10/10/96 |
New Jersey LCS® Total Knee System | Depuy, Inc.
Warsaw, IN 46581 |
Modification to the peg design of the porous-coated three-pegged patella component of the device. |
| P830055/S050
10/10/96 |
New Jersey LCS® Total Knee System | Depuy, Inc.
Warsaw, IN 46581 |
Change made to the deep dish rotating platform bridging bearing components of the device. |
| P830055/S051
10/11/96 |
New Jersey LCS® Total Knee System | Depuy, Inc.
Warsaw, IN 46581 |
Minor Design modification to the porous coated and textured femoral components of the device. |
| P840008/S054
10/8/96 |
Dornier Lithotripter and Dornier Lithotripter Transportable | Dornier Medical Systems
Kennesaw, GA 30144 |
Approval for 1) a patient automatic positioning feature; 2) patient data management software; 3) the Performa Ultrasound System; and 4) minor device modifications to both the Dornier Lithotripter and the Dornier Lithotripter Transportable. |
| P860003/S025
10/3/96 |
Therakos UVAR® Photophoresis System | Therakos, Inc., Johnson & Johnson
Exton, PA 19341 |
Approval for 1) packaging the three disposable treatment components (TPS101 Blood Tubing Set, TPS102 Photoceptor, and a commercially available blood centrifuge bowl) into a single procedural kit prior to sterilization; 2) packaging three procedural kits together in a single overshipper carton; 3) changing the sterilization cycle to provide for a longer exposure time, higher concentrations of ethylene oxide, and allows for a cooler product temperature at the beginning of the exposure phase of the cycle; and 4) the use of one thermocouple in each pallet to monitor product temperature during routine sterilization. |
| P860057/S004
10/17/96 |
Carpentier-Edwards® Perimount™ Bioprosthesis, Model 2700, and Carpentier-Edwards® Permount™ RSR Bioprosthesis Model 2800 | Baxter Healthcare Corporation
Santa Ana,CA 92711 |
Modification of your sterilization process to remove an aseptic sterilant-to-storage transfer process and replace it with a terminal sterilization process. |
| P860059/S077
10/7/96 |
IOPTEX PMMA Posterior Chamber Intraocular Lenses (IOLS) | Allergan Medical Optics
Irvine, Ca 92713-9534 |
Reduction of the incubation time for biological indicators used in sterility testing. |
| P870036/S040
10/25/97 |
Medtronic® Falcon® Coronary Balloon Dilatation Catheters | Medtronics Interventional
San Diego, CA 92121-2256 |
Approval for a change in the quality control procedures for the Medtronic® Falcon® family of Coronary Balloon Dilatation Catheters. |
| P870056/S003
10/17/96 |
Carpentier-Edwards® Bioprosthesis, Models 2625 and 6625 | Baxter Healthcare Corporation
Santa Ana, CA 92711-1150 |
Modification of your sterilization process to remove an aseptic sterilant-to-storage transfer process and replace it with a terminal sterilization process. |
| P870077/S003
10/17/96 |
Carpentier-Edwards® Duraflex™ Bioprosthesis, Models 6625-LP and 6625 ESR-LP | Baxter Healthcare Corporation
Santa Ana, Ca 92711-1150 |
Modification of your sterilization process to remove an aseptic sterililant-to-storage transfer process and replace it with a terminal sterilization process. |
| P880006/S024
10/30/96 |
APS II 3003 Programmer with Model 3203A Function Pack | Pacesetter, Inc.
Sylmar, Ca 91392-9221 |
Approval for the Model 3203A Function Pack for use with the APS II Programmer. |
| P880085/S003
10/7/96 |
IOPTEX PMMA Anterior Chamber IOLs | Allergan Medical Optics
Irvine, CA 92713-9534 |
Reduction of the incubation time for biological indicators used in sterility testing. |
| P880086/S035
10/9/96 |
Synchrony, Synchrony II & III Solus, Solus II & Trilogy Pacemakers | Siemens-Pacesetter, Inc.
Sylmar, CA 91392-9221 |
Modification of labeling to include a "cellular tested" logo to the shelf package of the following pacemaker models: Phoenix 2 (2005/2008/2009), Paragon (2010/2011/2012), Paragon II (2016), Synchrony (2020), Synchrony II (2022/2023), Synchrony III (2028/2029), Solus (2002/2003), Solus II (2006/2007), Trilogy (2350/2308/2250). |
| P880091/S008
10/17/96 |
UV-Absorbing Elastimide™ Models AQ-1016VL, AQ-2003VL, AQ-2010VL Posterior Chamber Intraocular Lenses (IOLS) | Starr Surgical Company
Monrovia, Ca 91016 |
Approval for Tier A Models A1-1016VL, AQ-2003VL, and AQ-2010VL. |
| P890003/S046
10/30/96 |
Medtronic 9766A/9766AL Programming Head | Medtronic, Inc.
Minneapolis, MN 55432-3576 |
Approval for the Model 9766AQ and Model 9766AL Programmer Heads for use with the Model 9790 and 9790C Programmers. |
| P890003/S47 | Synergyst II, Elite & Legend Pulse Generators | Medtronic, Inc.
Minneapolis, MN 55432-3576 |
Approval for the Medtronic Model 9892E Software for use with the Models 9790 and 9790C |
| P890023/S006
10/2/96 |
Ocufilcon D Cast Molded Soft Contact Lenses | Ocular Sciences/American Hydron
S.San Francisco, CA 94080 |
Alternate manufacturing facility at Reliant Close, Chandlers Ford Industrial Estate, Chandlers Ford, Eastleigh, Hampshire, S053 4ND, England. |
| P900061/S027
10/22/96 |
Medtronic® Models Implantable Arrhythmia Management Devices | Medtornic, Inc.
Minneapolis, MN 55432-3576 |
Approval for extending the shelf life to 18 months for the models 7219 B/D/E, 7202 D/E Jewel, 7220 B/C/D/E/ Jewel Plus and 7221 B/C/CX/D/E/ Microjewel™. |
| P910020/S016
10/16/96 |
RX5000 Version 2.00.01 Software | Intermedics, Inc.
Angleton, TX 77515 |
Approval for the RX5000 Version 2.00.01 Software for use with the RX5000 Model 522-12 Programmer to program the Marathon Pacing System. |
| P930016/S001
10/15/96 |
VISX Excimer Laser System Models "B" and "C" for Photorefractive Keratectomy (PRK) | VISX, Inc.
Santa Clara, CA 95051-0703 |
Labeling changes (i.e., minor editorial changes to the patient information booklet, contrast sensitivity/glare precautionary statement in lieu of a postapproval contrast sensitivity study, and definitions of potential risks with PRK). |
| P930031/S002
10/7/96 |
Wallstent® Transjugular Intrahepatic Portosystemic Shunt (TIPS) Endoprosthesis | Schneider (USA) Inc.
Minneapolis, MN 55442 |
Addition of the 12 mm diameter stent, and the HALO™ Radiopaque Wire. |
| P930034/S006
10/22/96 |
Excimed UV200 LA and SVS Apex | Summit Technology, Inc.
Waltham, MA 02154 |
Approval for discontinuing further follow-up and report of the <6.0 mm subjects in accordance with the post approval requirements. |
| P940013/S005
10/7/96 |
Precision™ UV (Vasurfilcon) | Wesley-Jessen
Des Plaines, IL 60018 |
Approval for the tinting of the device with an alternate, non-reactive, light blue-green locator tint (D&C Green No. 6, C.I. No. 61565) Using an in-monomer tinting process for the Precision™ UN (Vasurfilcon A) Hydrophilic Contact Lens for extended wear. |
| P940029/S001
10/21/96 |
Papnet® Testing System | Neuromedical Systems, Inc.
Suffern, NY 10901 |
Approval for a second indication for use. |
| P940031/S004
10/18/96 |
Vigor™ DR Pacemaker System | Guidant Corporation
St. Paul, MN 55112 |
New Pulse Generator Model the Vigor® DR Family of Pacemaker Systems. |
| P950014/S002
10/16/96 |
Mobile Prostatron | EDAP Intl., Corporation
Cambridge, MA 02139 |
Approval for a mobile version of the Prostatron. |
| P950014/S004
10/29/96 |
Prostatron | EDAP Intl., Corporation
Cambridge, MA 02139 |
Upgrades in 1) the Luxtron Thermometry Unit from Model 3000-4 to Model 3100-2) the computer processor from 386 to pentium; and 3) the software from version 3.07 to version 3.09. |
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