PMA P130008S112

Device: Model 4063 Inspire Stimulation Lead, Model 4340 Inspire Sensing Lead
Applicant: Inspire Medical Systems
PMA number: P130008
Supplement: S112
Product code: MNQ
Decision date: 2024-06-20
Classification: Anesthesiology
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Approval order statement: updates to the manufacturing processes of the Model 4063 Stimulation Lead and the Model 4340 Sensing Lead associated with the Outer Diameter of the IS-1 connector

Current openFDA PMA Record#

Device: Model 4063 Inspire Stimulation Lead, Model 4340 Inspire Sensing Lead
Applicant: Inspire Medical Systems
PMA number: P130008
Supplement: S112
Product code: MNQ
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Decision date: 2024-06-20
Decision code: OK30
Date received: 2024-05-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: updates to the manufacturing processes of the Model 4063 Stimulation Lead and the Model 4340 Sensing Lead associated with the Outer Diameter of the IS-1 connector