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FDA PMA

Implant, hearing, active, middle ear, partially implanted

Número do PMA: P010023 · 2020-10-28

RequerenteOtotronix, LLC
Data da decisão2020-10-28
Número PMAP010023
Código do produtoMPV
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoEN

Resumo do dispositivo

Implant, hearing, active, middle ear, partially implanted is the device name listed in this FDA 510(k) record. The listed applicant is Ototronix, LLC. It received FDA 510(k) clearance on 2020-10-28. The device is classified under product code MPV. It was reviewed by the EN advisory panel.

Perguntas frequentes

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

Implant, hearing, active, middle ear, partially implanted is a medical device that received FDA 510(k) clearance on 2020-10-28. The listed applicant is Ototronix, LLC.

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

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

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

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

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

The FDA product code for Implant, hearing, active, middle ear, partially implanted is MPV.

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Fonte oficial

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