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FDA PMA

透皮植入式義肢及三尖瓣

PMA 核准號:P230013 · 2026-09-16

決定日期2026-09-16
PMA 編號P230013
產品代碼NPW
器械分類3 類
醫療專科U
諮詢委員會履歷

器材摘要

Percutaneously Delivered Prostheses and Tricuspid Valves 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 2026-09-16. The device is classified under product code NPW. It was reviewed by the CV advisory panel.

常見問題

What is the Percutaneously Delivered Prostheses and Tricuspid Valves?

Percutaneously Delivered Prostheses and Tricuspid Valves is a medical device that received FDA 510(k) clearance on 2026-09-16. The listed applicant is Edwards Lifesciences, LLC.

When did Percutaneously Delivered Prostheses and Tricuspid Valves receive FDA 510(k) clearance?

The clearance date for Percutaneously Delivered Prostheses and Tricuspid Valves can be found in the official FDA records.

誰是經皮植入義肢和三尖瓣的登記申請人?

The FDA 510(k) record lists Edwards Lifesciences, LLC as the applicant. This does not by itself establish the device manufacturer.

FDA產品代碼是什麼?Percutaneously Delivered Prostheses 和 Tricuspid Valves?

FDA產品代碼為經皮植入假體和三尖瓣的為NPW。

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官方來源

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