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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 NumberS022
Date Received08/02/1996
Decision Date11/08/1996
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
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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