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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 DEFIBRILLAATOR SYSTEM
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP910023
Supplement NumberS036
Date Received08/24/1998
Decision Date11/04/1998
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the Ventritex(R) Profile(TM) II Tiered-Therapy Defibrillator System (Models V-184F and V-184HV3), Profile(TM) MD Tiered-Therapy Defibrillator System (Models V-186F and V-186HV3), Model 1500 Programmer Application Software Version 5.2, and Test Can Model AC-PFL-TCN.
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