FDA PMA

Implant, auditory brainstem

Número do PMA: P000015 · 2026-04-30

RequerenteCochlear Americas

Data da decisão2026-04-30

Número PMAP000015

Código do produtoMHE

Classe do DispositivoClasse 3

Especialidade MédicaU

Comité consultivoEN

Resumo do dispositivo

Implant, auditory brainstem is the device name listed in this FDA 510(k) record. The listed applicant is Cochlear Americas. It received FDA 510(k) clearance on 2026-04-30. The device is classified under product code MHE. It was reviewed by the EN advisory panel.

Perguntas frequentes

What is the Implant, auditory brainstem?

Implant, auditory brainstem is a medical device that received FDA 510(k) clearance on 2026-04-30. The listed applicant is Cochlear Americas.

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

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

Who is the listed applicant for Implant, auditory brainstem?

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

What is the FDA product code for Implant, auditory brainstem?

The FDA product code for Implant, auditory brainstem is MHE.

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Fonte oficial

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