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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 NumberS004
Date Received12/02/1997
Decision Date12/04/1997
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 2833 version 3. 0 which corrects a hardware limit anomaly.
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