- Device
- Inspire II Upper Airway Stimulator
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S063
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2021-03-12
- Decision code
- APPR
- Date received
- 2020-12-14
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for:1) Updates to the System Implant Manual to include an alternative implant technique for the sensing lead ; and2) Updates to the MRI Guidelines in conjunction with the update to the System Implant Manual