Inspire Upper Airway Stimulation (UAS) system
FDA premarket approval P130008/S118 · decided 2025-02-14
Approval details
- PMA number
- P130008
- Supplement
- S118
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Inspire Upper Airway Stimulation (UAS) system
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2025-01-16
- Decision date
- 2025-02-14
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- for labeling changes to add warning for the use of Inspire UAS during an MRI scan
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