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FDA PMA

內血管系統用於治療升主动脉及弓部病灶

PMA 核准號:P250033 · 2026-09-21

決定日期2026-09-21
PMA 編號P250033
產品代碼SDZ
器械分類3 類
醫療專科U
諮詢委員會履歷

器材摘要

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.

常見問題

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.

誰是升主动脉和主动脉弓病变內血管系統治療的登記申請人?

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

FDA產品代碼是什麼?用於治療升主动脉和主动脉弓病灶的內血管系統?

FDA對治療升主动脉和主动脉弓損傷的內血管系統產品代碼為SDZ。

相關臨床試驗

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官方來源

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