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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.
 
DeviceNEXUS Aortic Arch Stent Graft System
Generic NameEndovascular System for Treatment of Ascending Aorta and Aortic Arch Lesions
ApplicantEndospan , Ltd.
105 Alta Meadows Rd.
Alta, WY 83414
PMA NumberP250033
Supplement NumberS004
Date Received06/23/2026
Decision Date09/21/2026
Product Code SDZ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for a 3 year shelf-life for the NEXUS Aortic Arch Stent Graft System
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