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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 AV II/III DR AICD SYSTEMS
Generic Nameimplantable cardioverter defibrillator
ApplicantCARDIAC PACEMAKERS, INC.
PMA NumberP960040
Supplement NumberS008
Date Received12/03/1998
Decision Date12/08/1998
Docket Number N
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 software application model 2843 version 2. 7 for use with ventak(r) av ii/iii(tm) systems.
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