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Device | CADET V-105 C AND D AND V-115 C AND D PULSE GENERATORS & SOFTWARE VERSION 4.1 FOR THE PROGRAMMER MDL PR-1500 |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S012 |
Date Received | 06/30/1995 |
Decision Date | 12/22/1995 |
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 CADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM WITH "C" AND "D" HEADER STYLES FOR CADET V-105 AND V-115, AND PROGRAMMER MODEL PR-1500 SOFTWARE VERSION 4.1 |