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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 | S039 |
Date Received | 01/23/2019 |
Decision Date | 04/14/2020 |
Product Code |
MNQ |
Docket Number | 20M-1299 |
Notice Date | 06/25/2020 |
Advisory Committee |
Anesthesiology |
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 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. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |