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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 III DR PULSE GENERATOR AND VENTAK AV DR SOFTWARE APPLICATION
Generic Nameimplantable cardioverter defibrillator
ApplicantCARDIAC PACEMAKERS, INC.
PMA NumberP960040
Supplement NumberS006
Date Received04/22/1998
Decision Date08/31/1998
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the ventak(r) av iii dr aicd(tm) system with model 2843 software, version 2. 6, the use of version 2. 6 with the ventak(r) av ii dr system and modifications to the physician's manual and the dr system and modifications tot he physicians's manual and the patient's manual.
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