Inspire® Upper Airway Stimulation (UAS)
FDA premarket approval P130008/S120 · decided 2025-04-23
Approval details
- PMA number
- P130008
- Supplement
- S120
- Supplement type
- 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
- 2025-03-26
- Decision date
- 2025-04-23
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- notification of a change to the weld block plating supplier
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.