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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 DDD FAMILY OF AICD SYSTEMS
ApplicantGUIDANT CORP.
PMA NumberP960040
Supplement NumberS005
Date Received01/22/1998
Decision Date02/02/1998
Advisory Committee Anesthesiology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes in the ventak(r) av ii physician's manual and device warranty.
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