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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.
 
DeviceTHE ANEURX STENT SYSTEM
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantMedtronic Vascular
3576 UNOCAL PLACE
SANTA ROSA, CA 95403-1774
PMA NumberP990020
Supplement NumberS012
Date Received02/06/2003
Decision Date06/19/2003
Withdrawal Date 12/20/2013
Product Code MIH 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE MODIFICATION TO THE MANUFACTURING PROCESS TO ALLOW THE ANEURX STENT GRAFT TO BE UNLOADED AND RELOADED INTO A NEW PMA-APPROVED DELIVERY SYSTEM.
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