|
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 | S022 |
Date Received | 08/02/1996 |
Decision Date | 11/08/1996 |
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 CADET HIGH-VOLTAGE CAN ICD MODELS V-105AC AND V-115AC, CADET TEST CAN MODEL AC-CDT-TCN, CADET TEST CABLE MODEL AC-CDT-TCB, CONTOUR HIGH-VOLTAGE CAN ICD MODELS V-135AC AND V-145AC, CONTOUR TEST CAN MODEL AC-TCN AND CONTOUR TEST CABLE MODEL AC-TCB |