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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 NameEVT ABDOMINAL AORTIC TUBE/EVT ABDOMINAL AORTIC BIF
ApplicantGUIDANT CORP.
PMA NumberP990017
Supplement NumberS003
Date Received11/01/1999
Decision Date03/29/2000
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for shelf life extension test protocol.
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