PMA P130008S022
- Device
- Inspire II Upper Airway Stimulator
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S022
- Product code
- MNQ
- Decision date
- 2017-09-11
- Classification
- Stimulator, Hypoglossal Nerve, Implanted, Apnea
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- Inspire II Upper Airway Stimulator
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S022
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2017-09-11
- Decision code
- APPR
- Date received
- 2017-03-29
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.