Genio® System 2.1
FDA premarket approval P240024/S001 · decided 2025-10-03
Approval details
- PMA number
- P240024
- Supplement
- S001
- 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
- 2025-10-03
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Mont-Saint-Guibert
- Statement
- approval of the Post Approval Study protocol for the New Enrollment Study (BREATHE Study)
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