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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP910023
Supplement NumberS047
Date Received06/14/2000
Decision Date10/27/2000
Product Code LWS 
Docket Number 01M-0041
Notice Date 01/29/2001
Advisory Committee Cardiovascular
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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