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FDA PMA

Stimulator, hypoglossal nerve, implanted, apnea

PMA Number: P240024 · 2026-07-30

ApplicantNyxoah S.A.
Decision Date2026-07-30
PMA NumberP240024
Product CodeMNQ
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeAN

Device Summary

Stimulator, hypoglossal nerve, implanted, apnea is the device name listed in this FDA 510(k) record. The listed applicant is Nyxoah S.A.. It received FDA 510(k) clearance on 2026-07-30. The device is classified under product code MNQ. It was reviewed by the AN advisory panel.

Frequently Asked Questions

What is the Stimulator, hypoglossal nerve, implanted, apnea?

Stimulator, hypoglossal nerve, implanted, apnea is a medical device that received FDA 510(k) clearance on 2026-07-30. The listed applicant is Nyxoah S.A..

When did Stimulator, hypoglossal nerve, implanted, apnea receive FDA 510(k) clearance?

The clearance date for Stimulator, hypoglossal nerve, implanted, apnea can be found in the official FDA records.

Who is the listed applicant for Stimulator, hypoglossal nerve, implanted, apnea?

The FDA 510(k) record lists Nyxoah S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stimulator, hypoglossal nerve, implanted, apnea?

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

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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