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FDA PMA

Endovascular System for Treatment of Ascending Aorta and Aortic Arch Lesions

PMA Number: P250033 · 2026-09-21

ApplicantEndospan , Ltd.
Decision Date2026-09-21
PMA NumberP250033
Product CodeSDZ
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCV

Device Summary

Endovascular System for Treatment of Ascending Aorta and Aortic Arch Lesions is the device name listed in this FDA 510(k) record. The listed applicant is Endospan , Ltd.. It received FDA 510(k) clearance on 2026-09-21. The device is classified under product code SDZ. It was reviewed by the CV advisory panel.

Frequently Asked Questions

What is the Endovascular System for Treatment of Ascending Aorta and Aortic Arch Lesions?

Endovascular System for Treatment of Ascending Aorta and Aortic Arch Lesions is a medical device that received FDA 510(k) clearance on 2026-09-21. The listed applicant is Endospan , Ltd..

When did Endovascular System for Treatment of Ascending Aorta and Aortic Arch Lesions receive FDA 510(k) clearance?

The clearance date for Endovascular System for Treatment of Ascending Aorta and Aortic Arch Lesions can be found in the official FDA records.

Who is the listed applicant for Endovascular System for Treatment of Ascending Aorta and Aortic Arch Lesions?

The FDA 510(k) record lists Endospan , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Endovascular System for Treatment of Ascending Aorta and Aortic Arch Lesions?

The FDA product code for Endovascular System for Treatment of Ascending Aorta and Aortic Arch Lesions is SDZ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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