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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nametiered therapy implantable defibrillator
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP910023
Supplement NumberS039
Date Received02/08/1999
Decision Date03/01/1999
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to provide the standard medic alert(r) information with the ventritex implantable cardiovertor defibrillators.
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