|
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 | S011 |
Date Received | 05/15/1995 |
Decision Date | 10/31/1995 |
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 PROGRAMMER SOFTWARE VERSION 4.0 WITH THE CADENCE MODELS V-100, V-110 OR V-112 IMPLANTABLE DEFIBRILLATOR |