主動脈瓣膜，置換瓣膜，經皮置入
PMA 核准號：P110021 · 2016-03-22
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器材摘要
Aortic valve, prosthesis, percutaneously delivered is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2016-03-22. The device is classified under product code NPT. It was reviewed by the CV advisory panel.
常見問題
What is the Aortic valve, prosthesis, percutaneously delivered?
Aortic valve, prosthesis, percutaneously delivered is a medical device that received FDA 510(k) clearance on 2016-03-22. The listed applicant is Edwards Lifesciences, LLC.
When did Aortic valve, prosthesis, percutaneously delivered receive FDA 510(k) clearance?
The clearance date for Aortic valve, prosthesis, percutaneously delivered can be found in the official FDA records.
誰是主动脉瓣、置換瓣膜，經皮植入的登記申請人？
The FDA 510(k) record lists Edwards Lifesciences, LLC as the applicant. This does not by itself establish the device manufacturer.
FDA產品代碼為Aortic valve, prosthesis, percutaneously delivered是什麼？
FDA對於經皮植入的主动脉瓣，置換物的產品代碼為NPT。
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
在 FDA 資料庫中查看 →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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