PMA P240024S001
- Device
- Genio® System 2.1
- Applicant
- Nyxoah S.A.
- PMA number
- P240024
- Supplement
- S001
- Product code
- MNQ
- Decision date
- 2025-10-03
- Classification
- Anesthesiology
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Approval order statement
- approval of the Post Approval Study protocol for the New Enrollment Study (BREATHE Study)
Current openFDA PMA Record#
- Device
- Genio® System 2.1
- Applicant
- Nyxoah S.A.
- PMA number
- P240024
- Supplement
- S001
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2025-10-03
- 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 Post Approval Study protocol for the New Enrollment Study (BREATHE Study)