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FDA PMA

心臟瓣膜,非同種組織

PMA 核准號:P060025 · 2019-08-21

決定日期2019-08-21
PMA 編號P060025
產品代碼LWR
器械分類3 類
醫療專科U
諮詢委員會履歷

器材摘要

heart-valve, non-allograft tissue is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2019-08-21. The device is classified under product code LWR. It was reviewed by the CV advisory panel.

常見問題

What is the heart-valve, non-allograft tissue?

heart-valve, non-allograft tissue is a medical device that received FDA 510(k) clearance on 2019-08-21. The listed applicant is Medtronic, Inc..

When did heart-valve, non-allograft tissue receive FDA 510(k) clearance?

The clearance date for heart-valve, non-allograft tissue can be found in the official FDA records.

誰是心臟瓣膜、非同種組織的登記申請人?

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。

FDA心臟瓣膜非同種組織產品代碼是什麼?

FDA對心臟瓣膜、非同種組織產品編碼為LWR。

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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