Model 2740 Inspire Programmer; Model 2740S/C SleepSync Programming System
FDA premarket approval P130008/S129 · decided 2025-09-29
Approval details
- PMA number
- P130008
- Supplement
- S129
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Model 2740 Inspire Programmer; Model 2740S/C SleepSync Programming System
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2025-07-01
- Decision date
- 2025-09-29
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- device labeling updates for the Model 2740 Inspire Programmer and Model 2740S/C SleepSync Programming System addressing the reset of the implantable pulse generator (IPG) caused by telemetry communication errors.
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