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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 PRX AICD SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namepulse generator
ApplicantGUIDANT CORP.
PMA NumberP910077
Supplement NumberS021
Date Received07/18/1997
Decision Date08/08/1997
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for software modifications to the model 2090 multiple application utility (mau).
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