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Device | CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S047 |
Date Received | 06/14/2000 |
Decision Date | 10/27/2000 |
Product Code |
LWS |
Docket Number | 01M-0041 |
Notice Date | 01/29/2001 |
Advisory Committee |
Cardiovascular |
Supplement Type | Panel Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE PHOTON(TM) DR ICD SYSTEM PROGRAMMER SOFTWARE, MODEL AC-IP IS-1 RECEPTABLE PLUG, AND MODEL 442-2 TORQUE DRIVER/TORQUE WRENCH. THE DEVICE IS INDICATED FOR USE IN PATIENTS WITH A HISTORY OF HEMODYNAMICALLY COMPROMISING VENTRICULAR TACHYARRHYTHMIAS. THESE PATIENTS MAY HAVE EXPERIENCED A CARDIAC ARREST NOT ASSOCIATED WITH ACUTE MYOCARDIAL INFARCTION OR HAVE VENTRICULAR TACHYARRHYTHMIAS. IN ADDITION, THE PULSE GENERATOR CAN BE USED IN PATIENTS WHOSE PRIMARY THERAPY FOR HEMODYNAMICALLY SIGNIFICANT, SUSTAINED VENTRICULAR TACHYCARDIA IS ANTITACHYCARDIA PACING; THE DEFIBRILLATION CAPABILITIES OF THE DEVICE PROVIDE HIGH-ENERGY THERAPY IN THE EVENT THAT THE ARRHYTHMIA ACCELERATES. THE PULSE GENERATOR CAN BE IMPLANTED IN EITHER THE PECTORAL REGION OR THE ABDOMINAL REGION, AT THE PHYSICIAN'S DISCRETION. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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