PMA P240024

Device: Genio® System 2.1
Applicant: Nyxoah S.A.
Product code: MNQ
Decision date: 2025-11-06
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Approval order statement: approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P240024.

Current openFDA PMA Record#

Device: Genio® System 2.1
Applicant: Nyxoah S.A.
PMA number: P240024
Supplement: S002
Product code: MNQ
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Decision date: 2025-11-06
Decision code: APPR
Date received: 2025-09-05
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P240024.