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FDA PMA

Stimulator, hypoglossal nerve, implanted, apnea

PMA Number: P250013 · 2026-04-30

ApplicantLivaNova USA, Inc.
Decision Date2026-04-30
PMA NumberP250013
Product CodeMNQ
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeAN

Device Summary

Stimulator, hypoglossal nerve, implanted, apnea is a medical device manufactured by LivaNova USA, Inc.. It received FDA Premarket Approval (PMA) on 2026-04-30 under PMA number P250013. The device is classified under FDA product code MNQ. 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 Stimulator, hypoglossal nerve, implanted, apnea?

Stimulator, hypoglossal nerve, implanted, apnea is a medical device that received FDA Premarket Approval (PMA) on 2026-04-30. It is manufactured by LivaNova USA, Inc.. The PMA number is P250013.

When did Stimulator, hypoglossal nerve, implanted, apnea receive FDA PMA approval?

Stimulator, hypoglossal nerve, implanted, apnea received FDA PMA approval on 2026-04-30, under approval number P250013.

What company makes Stimulator, hypoglossal nerve, implanted, apnea?

Stimulator, hypoglossal nerve, implanted, apnea is manufactured by LivaNova USA, 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 Stimulator, hypoglossal nerve, implanted, apnea?

The FDA product code for Stimulator, hypoglossal nerve, implanted, apnea is MNQ.

What FDA device class is Stimulator, hypoglossal nerve, implanted, apnea?

Stimulator, hypoglossal nerve, implanted, apnea 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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