Inspire Upper Airway Stimulation
FDA premarket approval P130008/S131 · decided 2025-10-21
Approval details
- PMA number
- P130008
- Supplement
- S131
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Inspire Upper Airway Stimulation
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2025-09-25
- Decision date
- 2025-10-21
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- the implementation of a new Progressive Cavity Pump (PCP) and Nordson EFD Dispensing Robot to automate the epoxy mixing and dispensing steps of the Model 3150 IPG Battery Gluing Operation
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