PMA P130008S129

Device: Model 2740 Inspire Programmer; Model 2740S/C SleepSync Programming System
Applicant: Inspire Medical Systems
PMA number: P130008
Supplement: S129
Product code: MNQ
Decision date: 2025-09-29
Classification: Anesthesiology
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Approval order 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.

Current openFDA PMA Record#

Device: Model 2740 Inspire Programmer; Model 2740S/C SleepSync Programming System
Applicant: Inspire Medical Systems
PMA number: P130008
Supplement: S129
Product code: MNQ
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Decision date: 2025-09-29
Decision code: APPR
Date received: 2025-07-01
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order 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.