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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 DEFIBRILLAATOR SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nametiered therapy implantable defibrillator
ApplicantVENTRITEX, INC.
PMA NumberP910023
Supplement NumberS036
Date Received08/24/1998
Decision Date11/04/1998
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
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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