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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.
 
DeviceMEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantMedtronic Vascular
3576 Unocal Place
Santa Rosa, CA 95403
PMA NumberP100021
Supplement NumberS058
Date Received10/06/2016
Decision Date02/23/2017
Product Code MIH 
Advisory Committee Cardiovascular
Clinical TrialsNCT00705718
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval to transfer device component of the Talent Occluder to Endurant Stent Graft System.
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