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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 NameANCURE ENDOGRAFT SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Nameendovascular grafting system
ApplicantGUIDANT CORP.
PMA NumberP990017
Supplement NumberS013
Date Received11/27/2000
Decision Date12/28/2000
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of warning in the instructions for use.
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