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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 NameANEURX STENT GRAFT 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 NumberS010
Date Received09/13/2002
Decision Date12/23/2002
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 the format to be used for a clinical update that will be provided to physician users at least annually. The information contained in this update will be provided to the fda via the pma annual report.
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