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PMA de la FDA

Prosthesis, breast, noninflatable, internal, silicone gel-filled

Número de PMA: P230005 · 2026-09-25

SolicitanteMotiva USA, LLC
Fecha de decisión2026-09-25
Número PMAP230005
Código de productoFTR
Clase del dispositivoClase 3
Especialidad médicaG
Número de regulación21 CFR 8
Comité asesorSU

Resumen del dispositivo

Prosthesis, breast, noninflatable, internal, silicone gel-filled is the device name listed in this FDA 510(k) record. The listed applicant is Motiva USA, LLC. It received FDA 510(k) clearance on 2026-09-25. The device is classified under product code FTR. It was reviewed by the SU advisory panel.

Preguntas frecuentes

What is the Prosthesis, breast, noninflatable, internal, silicone gel-filled?

Prosthesis, breast, noninflatable, internal, silicone gel-filled is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is Motiva USA, LLC.

When did Prosthesis, breast, noninflatable, internal, silicone gel-filled receive FDA 510(k) clearance?

The clearance date for Prosthesis, breast, noninflatable, internal, silicone gel-filled can be found in the official FDA records.

Who is the listed applicant for Prosthesis, breast, noninflatable, internal, silicone gel-filled?

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

What is the FDA product code for Prosthesis, breast, noninflatable, internal, silicone gel-filled?

The FDA product code for Prosthesis, breast, noninflatable, internal, silicone gel-filled is FTR.

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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