FDA PMA

Ophthalmic Sealant

PMA Number: P130004 · 2021-11-02

ApplicantOcular Therapeutix, Inc.

Decision Date2021-11-02

PMA NumberP130004

Product CodePFZ

Device ClassClass 3

Medical SpecialtyU

Advisory CommitteeOP

Device Summary

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.

Frequently Asked Questions

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.