PMA P130008S137

Device: Model 3150 Implantable Pulse Generator (IPG)
Applicant: Inspire Medical Systems
PMA number: P130008
Supplement: S137
Product code: MNQ
Decision date: 2026-03-13
Classification: Anesthesiology
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Approval order statement: Approval for an additional sterilization chamber at the current validated sterilization vendor, Steris Applied Sterilization Technologies (AST), for the Model 3150 Implantable Pulse Generator (IPG).

Current openFDA PMA Record#

Device: Model 3150 Implantable Pulse Generator (IPG)
Applicant: Inspire Medical Systems
PMA number: P130008
Supplement: S137
Product code: MNQ
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Decision date: 2026-03-13
Decision code: OK30
Date received: 2026-02-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for an additional sterilization chamber at the current validated sterilization vendor, Steris Applied Sterilization Technologies (AST), for the Model 3150 Implantable Pulse Generator (IPG).