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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 NameTHE ANEURX STENT GRAFT WITH XPEDIENT DELIVERY SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Nametransluminal graft prosthesis for the treatment of abdominal aortic aneurysms
ApplicantMEDTRONIC AVE, INC.
PMA NumberP990020
Supplement NumberS013
Date Received02/07/2003
Decision Date05/23/2003
Product Code
MIH[ Registered Establishments with MIH ]
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 of modifications to the post-approval study for the device.
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