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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator (non-crt)
Applicant
St. Jude Medical
15900 valley view ct.
sylmar, CA 91342-3577
PMA NumberP910023
Supplement NumberS023
Date Received10/04/1996
Decision Date04/17/1997
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
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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