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FDA PMA

Pulmonary valve prosthesis percutaneously delivered

Número do PMA: P200015 · 2026-09-23

RequerenteEdwards Lifesciences, LLC
Data da decisão2026-09-23
Número PMAP200015
Código do produtoNPV
Classe do DispositivoClasse f
Especialidade MédicaU
Comité consultivoCV

Resumo do dispositivo

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.

Perguntas frequentes

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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Fonte oficial

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