PMA P130008S131

Device: Inspire Upper Airway Stimulation
Applicant: Inspire Medical Systems
PMA number: P130008
Supplement: S131
Product code: MNQ
Decision date: 2025-10-21
Classification: Anesthesiology
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Approval order statement: the implementation of a new Progressive Cavity Pump (PCP) and Nordson EFD Dispensing Robot to automate the epoxy mixing and dispensing steps of the Model 3150 IPG Battery Gluing Operation

Current openFDA PMA Record#

Device: Inspire Upper Airway Stimulation
Applicant: Inspire Medical Systems
PMA number: P130008
Supplement: S131
Product code: MNQ
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Decision date: 2025-10-21
Decision code: OK30
Date received: 2025-09-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the implementation of a new Progressive Cavity Pump (PCP) and Nordson EFD Dispensing Robot to automate the epoxy mixing and dispensing steps of the Model 3150 IPG Battery Gluing Operation