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FDA PMA

Valve, pulmonary

PMA Number: P180007 · 2026-05-07

ApplicantGyrus Acmi, Inc.
Decision Date2026-05-07
PMA NumberP180007
Product CodeNJK
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeAN

Device Summary

Valve, pulmonary is a medical device manufactured by Gyrus Acmi, Inc.. It received FDA Premarket Approval (PMA) on 2026-05-07 under PMA number P180007. The device is classified under FDA product code NJK. It was reviewed by the AN 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 Valve, pulmonary?

Valve, pulmonary is a medical device that received FDA Premarket Approval (PMA) on 2026-05-07. It is manufactured by Gyrus Acmi, Inc.. The PMA number is P180007.

When did Valve, pulmonary receive FDA PMA approval?

Valve, pulmonary received FDA PMA approval on 2026-05-07, under approval number P180007.

What company makes Valve, pulmonary?

Valve, pulmonary is manufactured by Gyrus Acmi, Inc..

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 Valve, pulmonary?

The FDA product code for Valve, pulmonary is NJK.

What FDA device class is Valve, pulmonary?

Valve, pulmonary 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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