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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)
Generic Namesoftware application
ApplicantGUIDANT CORP.
PMA NumberP910077
Supplement NumberS011
Date Received08/25/1995
Decision Date02/05/1996
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of model 2872 software application, rev. 4. 1 and model 2909 multiple application utility (mau) with the ventak prx ii/iii pulse generator and model 2950 prm.
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