|
Device | CADENCE(R) 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 | S020 |
Date Received | 06/14/1996 |
Decision Date | 09/09/1996 |
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 THE VENTRITEX CONTOUR CARDIOVERTER DEFIBRILLATOR SYSTEM (MODELS V-145D AND LT MODEL V-135D, PROGRAMMER SOFTWARE VERSION 4.1.5. AND ACCESSORIES |