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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.
 
DeviceEndurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System, Endurant II AUI Stent Graf
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantMedtronic Vascular
3576 Unocal Pl.
Santa Rosa, CA 95403
PMA NumberP100021
Supplement NumberS094
Date Received07/27/2021
Decision Date08/05/2021
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  
Manufacturing changes to be implemented by the first-tier supplier (Phillips) of components for the delivery systems of Valiant Captivia and Endurant series devices.
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