Inspire Upper Airway Stimulation
FDA premarket approval P130008/S089 · decided 2023-03-20
Approval details
- PMA number
- P130008
- Supplement
- S089
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Inspire Upper Airway Stimulation
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2022-08-19
- Decision date
- 2023-03-20
- Days to decision
- 213 days
- Decision code
- APPR
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- 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
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