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 NumberS004
Date Received04/30/2026
Decision Date07/30/2026
Product Code MNQ 
Advisory Committee Anesthesiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for firmware updates to the Activation Chip (AC) Model #2364 of the Genio® System 2.1 with associated updates to software documentation, risk management files, and verification and validation reports.
-
-