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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceGenio® System 2.1
Generic NameStimulator, hypoglossal nerve, implanted, apnea
ApplicantNyxoah S.A.
Rue Edouard Belin, 12
Mont-Saint-Guibert 1435
PMA NumberP240024
Date Received07/01/2024
Decision Date08/08/2025
Product Code MNQ 
Docket Number 25M-3345
Notice Date 08/25/2025
Advisory Committee Anesthesiology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order 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 years of age and older who have been confirmed to fail, cannot tolerate or are ineligible to be treated with current standard of care treatments including lifestyle modifications, positive airway pressure (PAP) treatments (such as continuous positive airway pressure [CPAP] or bi-level positive airway pressure [BiPAP] machines), oral appliances (such as mandibular advancement devices), and pharmacotherapy (such as tirzepatide). PAP failure is defined as an inability to eliminate OSA (residual AHI of greater than 15 despite PAP usage), and PAP intolerance is defined as: 1. Inability to use PAP (at least 5 nights per week of usage; usage defined as greater than 4 hours of use per night), or 2. Unwillingness to use PAP (PAP therapy initiated and subsequently discontinued by choice).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 
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