|
Device | CADET TIERED THERAPY DEFIBRILLATOR SYSTEM |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S018 |
Date Received | 04/08/1996 |
Decision Date | 06/11/1996 |
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 TWO HEADER CONFIGURATIONS (MODELS V-105/V115 AND MODELS V-105B/V-115B, AS PART OF THE CADET TIERED THERAPY DEFIBRILLATOR SYSTEM |