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FDA PMA

藥物釋放式經皮冠狀動脈腔內成形術導管

PMA 核准號:P250041 · 2026-09-18

決定日期2026-09-18
PMA 編號P250041
產品代碼OOB
器械分類3 類
醫療專科U
諮詢委員會履歷

器材摘要

Drug-eluting percutaneous transluminal coronary angioplasty catheter is the device name listed in this FDA 510(k) record. The listed applicant is MedAlliance, LLC. It received FDA 510(k) clearance on 2026-09-18. The device is classified under product code OOB. It was reviewed by the CV advisory panel.

常見問題

What is the Drug-eluting percutaneous transluminal coronary angioplasty catheter?

Drug-eluting percutaneous transluminal coronary angioplasty catheter is a medical device that received FDA 510(k) clearance on 2026-09-18. The listed applicant is MedAlliance, LLC.

When did Drug-eluting percutaneous transluminal coronary angioplasty catheter receive FDA 510(k) clearance?

The clearance date for Drug-eluting percutaneous transluminal coronary angioplasty catheter can be found in the official FDA records.

誰是藥物滲透經皮冠狀動脈腔內成形術導管之登記申請人?

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

FDA藥物滲透經皮冠狀動脈腔內成形術導管之產品代碼是什麼?

FDA 藥物滲透經皮冠狀動脈腔內成形術導管之產品代碼為 OOB。

相關臨床試驗

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官方來源

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