Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | VENTAK(R) PRX (TM) II AICD SYSTEM |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910077 |
Supplement Number | S010 |
Date Received | 06/26/1995 |
Decision Date | 02/05/1996 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR REPLACING THE CURRENT CONNECTOR TOP MATERIAL FOR AICD MODELS:1705, PRX II MODEL 1715, AND PRX III MODELS 1720/1725, PELLETHANE 2363-75D POLYURETHANE, WITH TECOTHANE TT1075D-M POLYURETHANE |
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