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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:P230035 · 2026-08-28

決定日期2026-08-28
PMA 編號P230035
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 Boston Scientific Corporation. It received FDA 510(k) clearance on 2026-08-28. 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 2026-08-28. The listed applicant is Boston Scientific Corporation.

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?

FDA 510(k) 記錄中將波士頓科學公司列為申請人。這並不單獨確立設備製造商。

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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