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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
Applicant MEDTRONIC INC.
PMA NumberP990020
Supplement NumberS041
Date Received10/01/2010
Decision Date10/27/2010
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Transfer of post sterilization inspections to an alternate site.
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