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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 Upper Airway Stimulation
Generic NameStimulator, hypoglossal nerve, implanted, apnea
ApplicantInspire Medical Systems
9700 63rd Ave. N., Suite 200
Maple Grove, MN 55369
PMA NumberP130008
Supplement NumberS089
Date Received08/19/2022
Decision Date03/20/2023
Product Code MNQ 
Docket Number 23M-1126
Notice Date 03/24/2023
Advisory Committee Anesthesiology
Clinical TrialsNCT02344108
Supplement TypePanel Track
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 Inspire Upper Airway Stimulation (UAS) the device is used to treat a subset of pediatric Down syndrome patients between the age of 13-18 with severe OSA (apnea-hypopnea index [AHI] of greater than or equal to 10 and less than or equal to 50) who: 1) Do not have complete concentric collapse at the soft palate level;2) Are contraindicated for or not effectively treated by adenotonsillectomy; 3) Have been confirmed to fail, or cannot tolerate positive airway pressure (PAP) therapy despite attempts to improve compliance; and4) Have followed standard of care in considering all other alternative/adjunct therapies. PAP failure is defined as an inability to eliminate OSA, and PAP intolerance is defined as: a. Inability to use PAP (greater than 5 nights per week of usage; usage defined as greater than 4 hours of use per night), or b. Unwillingness to use PAP (for example, a patient returns the PAP system after attempting to use it).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Post-Approval StudyShow Report Schedule and Study Progress
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