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FDA PMA

Cochlear implant with combined electrical stimulation and acoustic amplification

Número do PMA: P130016 · 2026-04-30

RequerenteCochlear Americas
Data da decisão2026-04-30
Número PMAP130016
Código do produtoPGQ
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoEN

Resumo do dispositivo

Cochlear implant with combined electrical stimulation and acoustic amplification 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 PGQ. It was reviewed by the EN advisory panel.

Perguntas frequentes

What is the Cochlear implant with combined electrical stimulation and acoustic amplification?

Cochlear implant with combined electrical stimulation and acoustic amplification is a medical device that received FDA 510(k) clearance on 2026-04-30. The listed applicant is Cochlear Americas.

When did Cochlear implant with combined electrical stimulation and acoustic amplification receive FDA 510(k) clearance?

The clearance date for Cochlear implant with combined electrical stimulation and acoustic amplification can be found in the official FDA records.

Who is the listed applicant for Cochlear implant with combined electrical stimulation and acoustic amplification?

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 Cochlear implant with combined electrical stimulation and acoustic amplification?

The FDA product code for Cochlear implant with combined electrical stimulation and acoustic amplification is PGQ.

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