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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 PMA record. The listed applicant is Ocular Therapeutix, Inc.. It received FDA Premarket Approval (PMA) on 2021-11-02 under PMA number P130004. The device is classified under FDA product code PFZ. It was reviewed by the OP advisory panel. This device is classified as Class III by the FDA. Class III devices subject to the most stringent regulatory controls. These devices generally require premarket approval (PMA) because they support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. PMA is the most stringent type of device marketing application required by the FDA. The device falls under the medical specialty of U. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires valid scientific evidence providing reasonable assurance of safety and effectiveness. PMA is generally required for Class III devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.

Frequently Asked Questions

What is Ophthalmic Sealant?

Ophthalmic Sealant is a medical device that received FDA Premarket Approval (PMA) on 2021-11-02. The listed applicant is Ocular Therapeutix, Inc.. The PMA number is P130004.

When did Ophthalmic Sealant receive FDA PMA approval?

Ophthalmic Sealant received FDA PMA approval on 2021-11-02, under PMA number P130004.

Who is the listed applicant for Ophthalmic Sealant?

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

What is the difference between PMA and 510(k)?

PMA (Premarket Approval) is the FDA process for evaluating Class III medical devices. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires valid scientific evidence providing reasonable assurance of safety and effectiveness. PMA is the most stringent type of device marketing application required by the FDA.

What is the FDA product code for Ophthalmic Sealant?

The FDA product code for Ophthalmic Sealant is PFZ.

What FDA device class is Ophthalmic Sealant?

Ophthalmic Sealant is classified as Class III by the FDA.

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.

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