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PMA de la FDA

Prosthesis, breast, inflatable, internal, saline

Número de PMA: P990075 · 2026-05-12

SolicitanteMentor Worldwide, LLC
Fecha de decisión2026-05-12
Número PMAP990075
Código de productoFWM
Clase del dispositivoClase 3
Especialidad médicaG
Número de regulación21 CFR 8
Comité asesorSU

Resumen del dispositivo

Prosthesis, breast, inflatable, internal, saline is the device name listed in this FDA 510(k) record. The listed applicant is Mentor Worldwide, LLC. It received FDA 510(k) clearance on 2026-05-12. The device is classified under product code FWM. It was reviewed by the SU advisory panel.

Preguntas frecuentes

What is the Prosthesis, breast, inflatable, internal, saline?

Prosthesis, breast, inflatable, internal, saline is a medical device that received FDA 510(k) clearance on 2026-05-12. The listed applicant is Mentor Worldwide, LLC.

When did Prosthesis, breast, inflatable, internal, saline receive FDA 510(k) clearance?

The clearance date for Prosthesis, breast, inflatable, internal, saline can be found in the official FDA records.

Who is the listed applicant for Prosthesis, breast, inflatable, internal, saline?

The FDA 510(k) record lists Mentor Worldwide, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Prosthesis, breast, inflatable, internal, saline?

The FDA product code for Prosthesis, breast, inflatable, internal, saline is FWM.

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Fuente oficial

Ver en la base de datos de la FDA →

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