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Device | CARDIAC AIRBAG / CARDIAC AIRBAG-T IMPLANTABLE CARDIOVERTER DEFIBRILLATORS |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P980023 |
Supplement Number | S014 |
Date Received | 03/10/2003 |
Decision Date | 05/14/2003 |
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 THE CARDIAC AIRBAG AND CARDIAC AIRBAG-AT AND ARE INTENDED TO PROVIDE VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING ARRHYTHMIAS IN INDIVIDUALS NOT EXPECTED TO HAVE GREATER THAN 3 EPISODES OF VENTRICULAR ARRHYTHMIAS REQUIRING ICD THERAPY DURING THE ANTICIPATED LIFETIME OF THE DEVICE. |