Inspire Upper Airway Stimulation System
FDA premarket approval P130008/S041 · decided 2019-07-22
Approval details
- PMA number
- P130008
- Supplement
- S041
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Inspire Upper Airway Stimulation System
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2019-04-23
- Decision date
- 2019-07-22
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for a change in the method used to incorporate serial numbers inside the Model 4063 leads IS-1 connector boot.
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