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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceGenio® System 2.1
Generic NameStimulator, hypoglossal nerve, implanted, apnea
ApplicantNyxoah S.A.
Rue Edouard Belin, 12
Mont-Saint-Guibert 1435
PMA NumberP240024
Supplement NumberS001
Date Received09/05/2025
Decision Date10/03/2025
Product Code MNQ 
Advisory Committee Anesthesiology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval of the Post Approval Study protocol for the New Enrollment Study (BREATHE Study)
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