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FDA PMA

支架,股浅動脈,藥物釋放

PMA 核准號:P180011 · 2026-08-21

決定日期2026-08-21
PMA 編號P180011
產品代碼NIU
器械分類3 類
醫療專科U
諮詢委員會履歷

器材摘要

Stent, superficial femoral artery, drug-eluting is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2026-08-21. The device is classified under product code NIU. It was reviewed by the CV advisory panel.

常見問題

What is the Stent, superficial femoral artery, drug-eluting?

Stent, superficial femoral artery, drug-eluting is a medical device that received FDA 510(k) clearance on 2026-08-21. The listed applicant is Boston Scientific Corp.

When did Stent, superficial femoral artery, drug-eluting receive FDA 510(k) clearance?

The clearance date for Stent, superficial femoral artery, drug-eluting can be found in the official FDA records.

誰是Stent, 淺表股動脈, 药物釋放應用的登記申請人?

The FDA 510(k) record lists Boston Scientific Corp as the applicant. This does not by itself establish the device manufacturer.

FDA產品代碼為Stent,表淺股動脈,藥物釋放型是什麼?

FDA對Stent, superficial femoral artery, drug-eluting的產品代碼為NIU。

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官方來源

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