PMA P130008S119

Device: Inspire II Upper Airway Stimulator
Applicant: Inspire Medical Systems
PMA number: P130008
Supplement: S119
Product code: MNQ
Decision date: 2025-03-04
Classification: Anesthesiology
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Approval order statement: The firm request approval for a manufacturing change to the Theta 1 Application-Specific Integrated Circuit (ASIC) component of the Model 3150 Implantable Pulse Generator (IPG) and an inspection change to the Model 3150 Printed Circuit Board Assembly (PCBA)

Current openFDA PMA Record#

Device: Inspire II Upper Airway Stimulator
Applicant: Inspire Medical Systems
PMA number: P130008
Supplement: S119
Product code: MNQ
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Decision date: 2025-03-04
Decision code: OK30
Date received: 2025-02-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: The firm request approval for a manufacturing change to the Theta 1 Application-Specific Integrated Circuit (ASIC) component of the Model 3150 Implantable Pulse Generator (IPG) and an inspection change to the Model 3150 Printed Circuit Board Assembly (PCBA)