PMA de la FDA

Implant, cochlear

Número de PMA: P960058 · 2026-09-18

SolicitanteAdvanced Bionics

Fecha de decisión2026-09-18

Número PMAP960058

Código de productoMCM

Clase del dispositivoClase 3

Especialidad médicaU

Comité asesorEN

Resumen del dispositivo

Implant, cochlear is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Bionics. It received FDA 510(k) clearance on 2026-09-18. The device is classified under product code MCM. It was reviewed by the EN advisory panel.

Preguntas frecuentes

What is the Implant, cochlear?

Implant, cochlear is a medical device that received FDA 510(k) clearance on 2026-09-18. The listed applicant is Advanced Bionics.

When did Implant, cochlear receive FDA 510(k) clearance?

The clearance date for Implant, cochlear can be found in the official FDA records.

Who is the listed applicant for Implant, cochlear?

The FDA 510(k) record lists Advanced Bionics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Implant, cochlear?

El código de producto de la FDA para Implante, coclear es MCM.

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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.