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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.
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Nameendovascular grafting system
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.