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The Tracker / April 2026 / P250033

PMA approved

NEXUS Aortic Arch Stent Graft System

Endospan , Ltd. · Apr 2, 2026 · P250033 · In the directory

FDA approved the NEXUS Aortic Arch Stent Graft System from Endospan , Ltd. on Apr 2, 2026 under P250033, an original premarket approval. The device falls under product code SDZ, Endovascular System For Treatment Of Ascending Aorta And Aortic Arch Lesions as a Class 3 device. The review panel was Cardiovascular.

FDA logged the submission as received on Aug 22, 2025. The decision came 223 days later.

This is the only decision on file for Endospan , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA approve under P250033?

P250033 is the FDA PMA for NEXUS Aortic Arch Stent Graft System, submitted by Endospan , Ltd.. FDA's decision date was Apr 2, 2026, under product code SDZ (Endovascular System For Treatment Of Ascending Aorta And Aortic Arch Lesions).

Who makes the NEXUS Aortic Arch Stent Graft System?

Endospan , Ltd., based in Alta, WY, is the applicant of record for P250033. The company is listed in the MedDevice Startups directory.

How long did the P250033 review take?

FDA received the submission on Aug 22, 2025 and issued its decision on Apr 2, 2026, 223 days later.

← All decisions in April 2026