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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 NameVENTAK(R) PRX (TM) II AICD SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
ApplicantGUIDANT CORP.
PMA NumberP910077
Supplement NumberS010
Date Received06/26/1995
Decision Date02/05/1996
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 replacing the current connector top material for aicd models:1705, prx ii model 1715, and prx iii models 1720/1725, pellethane 2363-75d polyurethane, with tecothane tt1075d-m polyurethane.
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