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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 System
Generic NameStimulator, hypoglossal nerve, implanted, apnea
ApplicantInspire Medical Systems
9700 63rd Ave. N., Suite 200
Maple Grove, MN 55369
PMA NumberP130008
Supplement NumberS090
Date Received10/17/2022
Decision Date06/08/2023
Product Code MNQ 
Docket Number 23M-2394
Notice Date 06/14/2023
Advisory Committee Anesthesiology
Clinical TrialsNCT02907398
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 to expand the indications for use to OSA patients with an upper limit baseline apnea-hypopnea index (AHI) to 100 (increase from <= 65 to <=100) and increasing the an upper limit body mass index (BMI) warning to 40 (increase from <=32 to <=40).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
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