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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceANEURX STENT GRAFT SYSTEM
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantMedtronic Vascular
3576 UNOCAL PLACE
SANTA ROSA, CA 95403-1774
PMA NumberP990020
Supplement NumberS034
Date Received03/06/2009
Decision Date09/13/2011
Withdrawal Date 12/20/2013
Product Code MIH 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR LABELING MODIFICATIONS TO INCORPORATE INFORMATION FROM COMPLETED CLINICAL STUDIES.
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