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FDA PMA

经皮输送的肺瓣膜置换术

PMA编号:P200015 · 2026-09-23

决定日期2026-09-23
PMA 编号P200015
产品代码NPV
设备分类第f类
医疗专科U
咨询委员会CV

器械摘要

Pulmonary 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 2026-09-23. The device is classified under product code NPV. It was reviewed by the CV advisory panel.

常见问题

What is the Pulmonary valve prosthesis percutaneously delivered?

Pulmonary valve prosthesis percutaneously delivered is a medical device that received FDA 510(k) clearance on 2026-09-23. The listed applicant is Edwards Lifesciences, LLC.

When did Pulmonary valve prosthesis percutaneously delivered receive FDA 510(k) clearance?

The clearance date for Pulmonary valve prosthesis percutaneously delivered can be found in the official FDA records.

Who is the listed applicant for Pulmonary valve prosthesis percutaneously delivered?

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 Pulmonary valve prosthesis percutaneously delivered?

The FDA product code for Pulmonary valve prosthesis percutaneously delivered is NPV.

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