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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
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
Date Received08/22/2025
Decision Date04/02/2026
Product Code SDZ 
Docket Number 26M-3730
Notice Date 04/07/2026
Advisory Committee Cardiovascular
Clinical TrialsNCT04471909
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
for the NEXUS Aortic Arch Stent Graft System. This device is indicated for the endovascular treatment of chronic dissections involving the aortic arch in patients who are at high risk for open surgical repair and who have appropriate anatomy
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 
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