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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 TUBE AND BIFURCATED ENDOGRAFT SYSTEMS
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Nameendovascular grafting system
ApplicantGUIDANT CORP.
PMA NumberP990017
Supplement NumberS012
Date Received11/06/2000
Decision Date02/15/2001
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification to the training program to allow less than 100% case support at centers that meet the established criteria. This change affects the conditions of approval described in the original approval order, dated suptember 28, 1999.
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