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PMA de la FDA

Mitral valve repair devices

Número de PMA: P220003 · 2026-09-23

SolicitanteEdwards Lifesciences, LLC
Fecha de decisión2026-09-23
Número PMAP220003
Código de productoNKM
Clase del dispositivoClase 3
Especialidad médicaU
Comité asesorCV

Resumen del dispositivo

Mitral valve repair devices 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 NKM. It was reviewed by the CV advisory panel.

Preguntas frecuentes

What is the Mitral valve repair devices?

Mitral valve repair devices is a medical device that received FDA 510(k) clearance on 2026-09-23. The listed applicant is Edwards Lifesciences, LLC.

When did Mitral valve repair devices receive FDA 510(k) clearance?

The clearance date for Mitral valve repair devices can be found in the official FDA records.

Who is the listed applicant for Mitral valve repair devices?

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 Mitral valve repair devices?

The FDA product code for Mitral valve repair devices is NKM.

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Fuente oficial

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