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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.
 
DeviceModel 2740 Inspire Programmer; Model 2740S/C SleepSync Programming System
Generic NameStimulator, hypoglossal nerve, implanted, apnea
ApplicantInspire Medical Systems
9700 63rd Ave. N., Suite 200
Maple Grove, MN 55369
PMA NumberP130008
Supplement NumberS129
Date Received07/01/2025
Decision Date09/29/2025
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  
device labeling updates for the Model 2740 Inspire Programmer and Model 2740S/C SleepSync Programming System addressing the reset of the implantable pulse generator (IPG) caused by telemetry communication errors.
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