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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 DR AICD
ApplicantGUIDANT CORP.
PMA NumberP960040
Supplement NumberS003
Date Received11/04/1997
Decision Date03/13/1998
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the ventak(r) av(tm) ii dr pulse generator models 1821 and 1826, model 2843 application software, version 1. 3 and revisions to the physician's manual, package labeling and patient's manual.
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