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PMA de la FDA

Implant, hearing, active, middle ear, totally implanted

Número de PMA: P090018 · 2026-06-03

SolicitanteEnvoy Medical Corporation
Fecha de decisión2026-06-03
Número PMAP090018
Código de productoOAF
Clase del dispositivoClase 3
Especialidad médicaU
Comité asesorEN

Resumen del dispositivo

Implant, hearing, active, middle ear, totally implanted is the device name listed in this FDA 510(k) record. The listed applicant is Envoy Medical Corporation. It received FDA 510(k) clearance on 2026-06-03. The device is classified under product code OAF. It was reviewed by the EN advisory panel.

Preguntas frecuentes

What is the Implant, hearing, active, middle ear, totally implanted?

Implant, hearing, active, middle ear, totally implanted is a medical device that received FDA 510(k) clearance on 2026-06-03. The listed applicant is Envoy Medical Corporation.

When did Implant, hearing, active, middle ear, totally implanted receive FDA 510(k) clearance?

The clearance date for Implant, hearing, active, middle ear, totally implanted can be found in the official FDA records.

Who is the listed applicant for Implant, hearing, active, middle ear, totally implanted?

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

What is the FDA product code for Implant, hearing, active, middle ear, totally implanted?

The FDA product code for Implant, hearing, active, middle ear, totally implanted is OAF.

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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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