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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 NumberS023
Date Received10/04/1996
Decision Date04/17/1997
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new version of programmer software for the ventritex(r) programmer pr-1500. The device, as modified, will be marketed under the trade name prs v4. 2h and is indicated for use with programmer pr-1500 and cadence pulse generator models v-105, v-115 and contour pulse generator models v-135, v-145.
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