|
Device | CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S013 |
Date Received | 07/31/1995 |
Decision Date | 05/13/1996 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ALTERNATIVE STERILIZATION PROCESS AND USE OF EASY-TO-RETRIEVE BIOLOGICAL INDICATORS |