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PMA de la FDA

Percutaneously Delivered Prostheses and Tricuspid Valves

Número de PMA: P230013 · 2026-09-16

SolicitanteEdwards Lifesciences, LLC
Fecha de decisión2026-09-16
Número PMAP230013
Código de productoNPW
Clase del dispositivoClase 3
Especialidad médicaU
Comité asesorCV

Resumen del dispositivo

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.

Preguntas frecuentes

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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Fuente oficial

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