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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 graft
PMA NumberP020004
Supplement NumberS023
Date Received05/21/2007
Decision Date06/26/2007
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 changes to the instructions for use to emphasize the appropriate withdrawal procedures for the delivery catheter and sheath if resistance is felt during removal. These changes included modifications to the directions for use as well as the addition of a warning/ precaution regarding the potential adverse events that may be associated with forcibly withdrawing the delivery catheter through the introducer sheath.