Inspire Upper Airway Stimulation (UAS)
FDA premarket approval P130008/S116 · decided 2025-06-03
Approval details
- PMA number
- P130008
- Supplement
- S116
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Inspire Upper Airway Stimulation (UAS)
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2024-11-27
- Decision date
- 2025-06-03
- Days to decision
- 188 days
- Decision code
- APPR
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- notification of updated silicone application instructions during the header attach operations of the Model 3028 Implantable Pulse Generator (IPG)
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