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FDA PMA

更換心臟瓣膜

PMA 核准號:P990064 · 2026-03-03

決定日期2026-03-03
PMA 編號P990064
產品代碼DYE
器械分類3 類
醫療專科C
法規編號21 CFR 8
諮詢委員會履歷

器材摘要

replacement Heart-valve is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2026-03-03. The device is classified under product code DYE. It was reviewed by the CV advisory panel.

常見問題

What is the replacement Heart-valve?

replacement Heart-valve is a medical device that received FDA 510(k) clearance on 2026-03-03. The listed applicant is Medtronic, Inc..

When did replacement Heart-valve receive FDA 510(k) clearance?

The clearance date for replacement Heart-valve can be found in the official FDA records.

誰是更換心臟瓣膜的登記申請人?

FDA 510(k) 記錄將美敦力公司(Medtronic, Inc.)列為申請人。這並不單獨確立該設備製造商。

替換心臟瓣膜的FDA產品代碼是什么?

FDA產品代碼,替換心臟瓣膜的為DYE。

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係,請查閱連結的官方來源。

官方來源

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資料來源為 FDA Open API。如需最新且權威的資訊,請始終參閱官方記錄。

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