Genio® System 2.1
FDA premarket approval P240024/S002 · decided 2025-11-06
Approval details
- PMA number
- P240024
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Genio® System 2.1
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Nyxoah S.A.
- Date received
- 2025-09-05
- Decision date
- 2025-11-06
- Days to decision
- 62 days
- Decision code
- APPR
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Mont-Saint-Guibert
- 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.
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