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Device | Inspire Upper Airway Stimulation |
Generic Name | Stimulator, hypoglossal nerve, implanted, apnea |
Applicant | INSPIRE MEDICAL SYSTEMS 9700 63RD AVENUE NORTH SUITE 200 MAPLE GROVE, MN 55369 |
PMA Number | P130008 |
Supplement Number | S089 |
Date Received | 08/19/2022 |
Decision Date | 03/20/2023 |
Product Code |
MNQ |
Docket Number | 23M-1126 |
Notice Date | 03/24/2023 |
Advisory Committee |
Anesthesiology |
Clinical Trials | NCT02344108
|
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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 Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Post-Approval Study | Show Report Schedule and Study Progress |