Inspire® Upper Airway Stimulation System
FDA premarket approval P130008/S096 · decided 2023-05-19
Approval details
- PMA number
- P130008
- Supplement
- S096
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Inspire® Upper Airway Stimulation System
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2023-04-19
- Decision date
- 2023-05-19
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval of the protocol for the post-approval study (PAS) protocol.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.