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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 II Upper Airway Stimulator
Generic NameStimulator, hypoglossal nerve, implanted, apnea
ApplicantInspire Medical Systems
9700 63rd Ave. N., Suite 200
Maple Grove, MN 55369
PMA NumberP130008
Supplement NumberS093
Date Received11/18/2022
Decision Date12/16/2022
Product Code MNQ 
Advisory Committee Anesthesiology
Clinical TrialsNCT04457154
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
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 indicated for use to treat a subset of patients with moderate to severe obstructive sleep apnea (OSA) (apnea-hypopnea index [AHI] of greater than or equal to 15 and less than or equal to 65). Inspire® UAS is used in adult patients 22 years of age and older who have been confirmed to fail or cannot tolerate positive airway pressure (PAP) treatments (such as continuous positive airway pressure [CPAP] or bi-level positive airway pressure [BPAP] machines) and who do not have a complete concentric collapse at the soft palate level.PAP failure is defined as an inability to eliminate OSA (AHI of greater than 15 despite PAP usage), and PAP intolerance is defined as:1) Inability to use PAP (greater than 5 nights per week of usage; usage defined as greater than 4 hours of use per night); or2) Unwillingness to use PAP (for example, a patient returns the PAP system after attempting to use it).Inspire® UAS is also indicated for use in patients between the ages of 18 and 21with moderate to severe OSA (15?AHI?65) 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, PAP therapy despite attempts to improve compliance; and4) Have followed standard of care in considering all other alternative/adjunct therapies.
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