|
Device | VENTAK(R) PRX(R) AICD(TM) SYSTEM |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910077 |
Supplement Number | S004 |
Date Received | 11/07/1994 |
Decision Date | 08/03/1995 |
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 PROGRAM DISK MODEL 2860 REVISION 11.2 SOFTWARE OF VENTAK PRX AICD SYSTEM |