Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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 NumberS003
Date Received03/09/2026
Decision Date06/08/2026
Product Code MNQ 
Advisory Committee Anesthesiology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the discontinuation of the External Stimulator (ES) and its removal from the surgical implantation workflow for the Genio® System 2.1, with associated updates to the Surgeon Manuals.
-
-