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FDA PMA

经皮植入的主动脉瓣,人工瓣膜

PMA编号:P140031 · 2026-09-23

决定日期2026-09-23
PMA 编号P140031
产品代码NPT
设备分类第3类
医疗专科U
咨询委员会CV

器械摘要

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

常见问题

What is the Aortic valve, prosthesis, percutaneously delivered?

Aortic 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 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.

Who is the listed applicant for Aortic 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 Aortic valve, prosthesis, percutaneously delivered?

The FDA product code for Aortic valve, prosthesis, percutaneously delivered is NPT.

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