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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.
 
DeviceInspire Model 4063 Leads; Inspire Model 4340 Leads
Generic NameStimulator, hypoglossal nerve, implanted, apnea
ApplicantInspire Medical Systems
9700 63rd Ave. N., Suite 200
Maple Grove, MN 55369
PMA NumberP130008
Supplement NumberS139
Date Received04/29/2026
Decision Date05/28/2026
Product Code MNQ 
Advisory Committee Anesthesiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for additional EO sterilization chambers (Chambers 02 and 21) at the current validated sterilization vendor, Steris Applied Sterilization Technologies (AST), for the Model 4063 Stimulation Lead and Model 4340 Sensing Lead
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