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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 II Aorto-Uni-Iliac (AUI) Stent Graft System, Endur
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantMedtronic Vascular
3576 Unocal Place
Santa Rosa, CA 95403
PMA NumberP100021
Supplement NumberS072
Date Received09/10/2018
Decision Date03/08/2019
Product Code MIH 
Advisory Committee Cardiovascular
Clinical TrialsNCT01534819
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 update to the Endurant Stent Graft IFU as well as the Endurant II/IIs Stent Graft IFU.
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