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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
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 NumberS022
Date Received08/02/1996
Decision Date11/08/1996
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 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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