PMA P130008S146

Device: Model 3150 IPG
Applicant: Inspire Medical Systems
PMA number: P130008
Supplement: S146
Product code: MNQ
Decision date: 2026-10-13
Classification: Anesthesiology
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Approval order statement: approval for dimensional modifications to the Model 3150 Implantable Pulse Generator (IPG) PCBA transport fixture and the implementation of an additional visual inspection step of the microcontroller unit (MCU) prior to final device assembly

Current openFDA PMA Record#

Device: Model 3150 IPG
Applicant: Inspire Medical Systems
PMA number: P130008
Supplement: S146
Product code: MNQ
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Decision date: 2026-10-13
Decision code: OK30
Date received: 2026-09-15
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for dimensional modifications to the Model 3150 Implantable Pulse Generator (IPG) PCBA transport fixture and the implementation of an additional visual inspection step of the microcontroller unit (MCU) prior to final device assembly