FDA PMA

Ophthalmic Sealant

Número do PMA: P130004 · 2021-11-02

RequerenteOcular Therapeutix, Inc.

Data da decisão2021-11-02

Número PMAP130004

Código do produtoPFZ

Classe do DispositivoClasse 3

Especialidade MédicaU

Comité consultivoOP

Resumo do dispositivo

Ophthalmic Sealant is the device name listed in this FDA 510(k) record. The listed applicant is Ocular Therapeutix, Inc.. It received FDA 510(k) clearance on 2021-11-02. The device is classified under product code PFZ. It was reviewed by the OP advisory panel.

Perguntas frequentes

What is the Ophthalmic Sealant?

Ophthalmic Sealant is a medical device that received FDA 510(k) clearance on 2021-11-02. The listed applicant is Ocular Therapeutix, Inc..

When did Ophthalmic Sealant receive FDA 510(k) clearance?

The clearance date for Ophthalmic Sealant can be found in the official FDA records.

Who is the listed applicant for Ophthalmic Sealant?

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

What is the FDA product code for Ophthalmic Sealant?

The FDA product code for Ophthalmic Sealant is PFZ.

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Fonte oficial

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