|
Device | VENTAK PRX 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 | S020 |
Date Received | 12/23/1996 |
Decision Date | 02/18/1997 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE MODIFICATION OF THE DIAGNOSTIC (SELF-TEST) FUNCTION OF THE MODEL 2909 MULTIPLE APPLICATION UTILITY (MAU) TO ACCOMMODATE VARIABILITY IN WATCH DOG TIMER (WDT) TIME-OUT PERIODS. |