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Device | CONVERT (MODEL V-191) AND CONVERT+ (MODEL V-195) SYSTEMS WITH APPLICATION SOFTWARE MODEL 3307 VERSION 4.9 |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S081 |
Date Received | 08/08/2005 |
Decision Date | 05/11/2006 |
Product Code |
NVZ |
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 CONVERT AND CONVERT+ ICD SYSTEMS WITH THE APPLICATION SOFTWARE MODEL 3307 VERSION 4.9. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CONVERT AND CONVERT+ ICD SYSTEMS AND IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING (MODEL V-195 ONLY) AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS. |