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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 AAADVANTAGE STENT GRAFT DELIVERY 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 NumberS039
Date Received04/01/2010
Decision Date05/21/2010
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a sterilization site located at isotron ireland, ltd. , in offaly, ireland.
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