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FDA PMA

Válvula aórtica, prótese, delivered percutaneamente

Número do PMA: P140031 · 2026-09-23

RequerenteEdwards Lifesciences, LLC
Data da decisão2026-09-23
Número PMAP140031
Código do produtoNPT
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoCV

Resumo do dispositivo

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.

Perguntas frequentes

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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Fonte oficial

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