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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
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator (non-crt)
Applicant
St. Jude Medical
15900 valley view ct.
sylmar, CA 91342-3577
PMA NumberP910023
Supplement NumberS036
Date Received08/24/1998
Decision Date11/04/1998
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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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