FDA PMA

Percutaneously Delivered Prostheses and Tricuspid Valves

PMA番号：P230013 · 2026-09-16

決定日2026-09-16

PMA番号P230013

製品コードNPW

デバイスクラスクラス3

診療科U

諮問委員会以下は、提供された医療機器規制テキストの日本語訳です。 --- **政策：medical-regulatory-v1** --- [ここに原文が記載されています] --- **会社名/製品名**：[ここに会社名または製品名が記載されています] **FDA**：食品医薬品局 **510(k)**：510(k)届出 **PMA**：プレマーケティング評価届出 **NCT**：臨床試験登録番号 **PMID**：PubMed ID **識別子**：[ここに識別子が記載されています] **URL**：[ここにURLが記載されています]

医療機器の概要

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.

よくある質問

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.

Who is the listed applicant for Percutaneously Delivered Prostheses and Tricuspid Valves?

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

What is the FDA product code for Percutaneously Delivered Prostheses and Tricuspid Valves?

The FDA product code for Percutaneously Delivered Prostheses and Tricuspid Valves is NPW.

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医療機器の概要

よくある質問

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