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FDA PMA

Ring, endocapsular

PMA Number: P010059 · 2017-01-26

ApplicantMorcher GmbH
Decision Date2017-01-26
PMA NumberP010059
Product CodeMRJ
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeOP

Device Summary

Ring, endocapsular is a medical device manufactured by Morcher GmbH. It received FDA Premarket Approval (PMA) on 2017-01-26 under PMA number P010059. The device is classified under FDA product code MRJ. 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 the manufacturer to submit clinical trial data demonstrating the safety and effectiveness of the device. 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 Ring, endocapsular?

Ring, endocapsular is a medical device that received FDA Premarket Approval (PMA) on 2017-01-26. It is manufactured by Morcher GmbH. The PMA number is P010059.

When did Ring, endocapsular receive FDA PMA approval?

Ring, endocapsular received FDA PMA approval on 2017-01-26, under approval number P010059.

What company makes Ring, endocapsular?

Ring, endocapsular is manufactured by Morcher GmbH.

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 the manufacturer to provide clinical data proving safety and effectiveness. PMA is the most stringent type of device marketing application required by the FDA.

What is the FDA product code for Ring, endocapsular?

The FDA product code for Ring, endocapsular is MRJ.

What FDA device class is Ring, endocapsular?

Ring, endocapsular is classified as Class III by the FDA.

Related Devices (Code: MRJ)

PMA P030023Ring, endocapsularOphtec BV

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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