PMA P240024S004

Device: Genio® System 2.1
Applicant: Nyxoah S.A.
PMA number: P240024
Supplement: S004
Product code: MNQ
Decision date: 2026-07-30
Classification: Anesthesiology
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Approval order statement: Approval for firmware updates to the Activation Chip (AC) Model #2364 of the Genio® System 2.1 with associated updates to software documentation, risk management files, and verification and validation reports.

Current openFDA PMA Record#

Device: Genio® System 2.1
Applicant: Nyxoah S.A.
PMA number: P240024
Supplement: S004
Product code: MNQ
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Decision date: 2026-07-30
Decision code: APPR
Date received: 2026-04-30
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for firmware updates to the Activation Chip (AC) Model #2364 of the Genio® System 2.1 with associated updates to software documentation, risk management files, and verification and validation reports.