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FDA PMA

Tissue adhesive for internal use

PMA Number: P130023 · 2017-07-27

ApplicantCohera Medical, Inc.
Decision Date2017-07-27
PMA NumberP130023
Product CodePJK
Device ClassClass 3
Medical SpecialtyG
Regulation Number21 CFR 8
Advisory CommitteeSU

Device Summary

Tissue adhesive for internal use is the device name listed in this FDA PMA record. The listed applicant is Cohera Medical, Inc.. It received FDA Premarket Approval (PMA) on 2017-07-27 under PMA number P130023. The device is classified under FDA product code PJK. It was reviewed by the SU 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 G. It is regulated under 21 CFR Part 8. 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 Tissue adhesive for internal use?

Tissue adhesive for internal use is a medical device that received FDA Premarket Approval (PMA) on 2017-07-27. The listed applicant is Cohera Medical, Inc.. The PMA number is P130023.

When did Tissue adhesive for internal use receive FDA PMA approval?

Tissue adhesive for internal use received FDA PMA approval on 2017-07-27, under PMA number P130023.

Who is the listed applicant for Tissue adhesive for internal use?

The FDA PMA record lists Cohera Medical, 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 Tissue adhesive for internal use?

The FDA product code for Tissue adhesive for internal use is PJK.

What FDA device class is Tissue adhesive for internal use?

Tissue adhesive for internal use is classified as Class III by the FDA.

Official Source

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

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