INSPIRE II UPPER AIRWAY STIMULATOR
FDA premarket approval P130008/S122 · decided 2025-05-16
Approval details
- PMA number
- P130008
- Supplement
- S122
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INSPIRE II UPPER AIRWAY STIMULATOR
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2025-04-18
- Decision date
- 2025-05-16
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- transfer of Ultrasonic Welder calibration services in-house at the manufacturer of Model 3150 IPG and enhance the calibration process to reduce equipment down time and ensure a more reliable production process
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