Genio® System 2.1
FDA premarket approval P240024 · decided 2025-08-08
Approval details
- PMA number
- P240024
- Trade name
- Genio® System 2.1
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Nyxoah S.A.
- Date received
- 2024-07-01
- Decision date
- 2025-08-08
- Days to decision
- 403 days
- Decision code
- APPR
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Mont-Saint-Guibert
- Statement
- Approval for The Nyxoah Genio System 2.1, which includes the Implantable Stimulator Model #2954, Surgical Template, External Stimulator, Disposable Patch, Activation Chip Model #2364, Charging Unit Model #2238, Sleep Lab Application, Repeater, and Smartphone Application. It is indicated for use in the treatment of moderate to severe Obstructive Sleep Apnea (OSA) (apnea-hypopnea index [AHI] of greater than or equal to 15 and less than or equal to 65). The device is intended for adult patients 22
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