Inspire II Upper Airway Stimulator
FDA premarket approval P130008/S065 · decided 2021-09-21
Approval details
- PMA number
- P130008
- Supplement
- S065
- Supplement type
- 135 Review Track For 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
- 2021-03-29
- Decision date
- 2021-09-21
- Days to decision
- 176 days
- Decision code
- APPR
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for two additional sterilization chambers for the sterilization of Model 3028 Implantable Pulse Generator (IPG) at the Inspire Medical Systems Incs contract manufacturer/sterilizer, Steris Isomedix.
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