PMA P130008

Device: Model 3150 IPG
Applicant: Inspire Medical Systems
PMA number: P130008
Supplement: S093
Product code: MNQ
Decision date: 2026-10-22
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Approval order statement: approval for the expansion of Inspire Medical's existing Model 3028 Implantable Pulse Generator (IPG) final device manufacturer's site to produce the Model 3150 IPG

Current openFDA PMA Record#

Device: Model 3150 IPG
Applicant: Inspire Medical Systems
PMA number: P130008
Supplement: S147
Product code: MNQ
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Decision date: 2026-10-22
Decision code: OK30
Date received: 2026-09-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for the expansion of Inspire Medical's existing Model 3028 Implantable Pulse Generator (IPG) final device manufacturer's site to produce the Model 3150 IPG