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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 VR OMDEL 1774/MODEL 1775 AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WITH MODEL 2841 SOFTWARE APPLICATION
Generic Nameimplantable cardioverter defibrillator
ApplicantCARDIAC PACEMAKERS, INC.
PMA NumberP960040
Supplement NumberS009
Date Received01/12/1999
Decision Date05/03/1999
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 the ventak(r) vr aicd(tm) system with model 2841 software, version 1. 4.
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