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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(R) TIERED THERAPY DEFIBRILLATOR SYSTEM
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP910023
Supplement NumberS022
Date Received08/02/1996
Decision Date11/08/1996
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CADET HIGH-VOLTAGE CAN ICD MODELS V-105AC AND V-115AC, CADET TEST CAN MODEL AC-CDT-TCN, CADET TEST CABLE MODEL AC-CDT-TCB, CONTOUR HIGH-VOLTAGE CAN ICD MODELS V-135AC AND V-145AC, CONTOUR TEST CAN MODEL AC-TCN AND CONTOUR TEST CABLE MODEL AC-TCB
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