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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 NumberS032
Date Received12/29/1997
Decision Date02/02/1998
Product Code
LWS
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for use of ventritex contour(tm) model v-145 and contour(tm) lt model v-135 pulse generators with the medtronic(r) transvene(r) leads and changes in the physician's manuals.
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