SleepSync Programmer
FDA premarket approval P130008/S092 · decided 2023-06-27
Approval details
- PMA number
- P130008
- Supplement
- S092
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SleepSync Programmer
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2022-11-14
- Decision date
- 2023-06-27
- Days to decision
- 225 days
- Decision code
- APPR
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for the updated SleepSync Programmer (Model 2740) which consists of the Inspire Programming Software Application (Model 2740S) that can be installed on customer owned devices and paired with the Inspire Programmer Cable (Model 2740C).
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