Inspire II Upper Airway Stimulator
FDA premarket approval P130008/S055 · decided 2020-11-16
Approval details
- PMA number
- P130008
- Supplement
- S055
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location 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
- 2020-07-10
- Decision date
- 2020-11-16
- Days to decision
- 129 days
- Decision code
- APPR
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval of manufacturing site located at Cirtec Medical, 99 Print Shop Rd, Enfield, CT 06082, USA, (for sterilization process for the finished device, Inspire Model 3028 IPG).
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