PMA P240024S003

Device: Genio® System 2.1
Applicant: Nyxoah S.A.
PMA number: P240024
Supplement: S003
Product code: MNQ
Decision date: 2026-06-08
Classification: Anesthesiology
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Approval order statement: Approval for the discontinuation of the External Stimulator (ES) and its removal from the surgical implantation workflow for the Genio® System 2.1, with associated updates to the Surgeon Manuals.

Current openFDA PMA Record#

Device: Genio® System 2.1
Applicant: Nyxoah S.A.
PMA number: P240024
Supplement: S003
Product code: MNQ
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Decision date: 2026-06-08
Decision code: APPR
Date received: 2026-03-09
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the discontinuation of the External Stimulator (ES) and its removal from the surgical implantation workflow for the Genio® System 2.1, with associated updates to the Surgeon Manuals.