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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 WITH XPEDIENT DELIVERY SYSTEM
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantMedtronic Vascular
3576 Unocal Pl.
Santa Rosa, CA 95403
PMA NumberP990020
Supplement NumberS014
Date Received07/14/2003
Decision Date08/08/2003
Withdrawal Date12/20/2013
Product Code MIH 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE IN THE MANUFACTURING PROCESS OF THE ANEURX STENT GRAFT WITH XPEDIENT DELIVERY SYSTEM WHICH INVOLVES A CHANGE IN THE METHOD OF THE JOINING PROCESS FROM ADHESIVE TO LASER-WELD FOR BOTH THE 16 FR AND 12 FR DELIVERY SYSTEMS.
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