|
Device | VENTAK(R) P3 AICD(TM) SYSTEM |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P930035 |
Supplement Number | S004 |
Date Received | 06/26/1995 |
Decision Date | 02/20/1996 |
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 THE ABOVE AICD MODELS, PELLETHANE 2363-75D POLYURETHANE, WITH TECOTHANE TT1075D-M POLYURETHANE |