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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(R) TIERED THERAPY DEFIBRILLATOR SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
ApplicantVENTRITEX, INC.
PMA NumberP910023
Supplement NumberS031
Date Received09/12/1997
Decision Date11/05/1997
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the ventritex cadence(r) and cadet(r) with the medtronic transvene(r) defibrillation leads.
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