Inspire® Upper Airway Stimulation
FDA premarket approval P130008/S130 · decided 2025-10-22
Approval details
- PMA number
- P130008
- Supplement
- S130
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Inspire® Upper Airway Stimulation
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2025-09-22
- Decision date
- 2025-10-22
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P130008/S089
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