PMA P130008S098

Device: Inspire Upper Airway Stimulation (UAS) System
Applicant: Inspire Medical Systems
PMA number: P130008
Supplement: S098
Product code: MNQ
Decision date: 2024-08-01
Classification: Anesthesiology
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Approval order statement: approval for a new implant device, the Inspire V Model 3150 Implantable Pulse Generator (IPG). The Model 3150 IPG is the new version of the currently approved Model 3028

Current openFDA PMA Record#

Device: Inspire Upper Airway Stimulation (UAS) System
Applicant: Inspire Medical Systems
PMA number: P130008
Supplement: S098
Product code: MNQ
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Decision date: 2024-08-01
Decision code: APPR
Date received: 2023-06-30
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for a new implant device, the Inspire V Model 3150 Implantable Pulse Generator (IPG). The Model 3150 IPG is the new version of the currently approved Model 3028