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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 ANEURX
PMA NumberP990020
Supplement NumberS001
Date Received11/18/1999
Decision Date12/10/1999
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The 30-day notice requested a change to add a supplier of expanded stents.
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