PMA P130008S083

Device: Inspire Respiratory Sensing Lead and Inspire Stimulation Lead
Applicant: Inspire Medical Systems
PMA number: P130008
Supplement: S083
Product code: MNQ
Decision date: 2022-04-07
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Approval order statement: Additional lathe equipment to be used to manufacture the terminal pin used in the connector assembly of the Inspire leads, Model 4340 and Model 4063, to increase production capacity.

Current openFDA PMA Record#

Device: Inspire Respiratory Sensing Lead and Inspire Stimulation Lead
Applicant: Inspire Medical Systems
PMA number: P130008
Supplement: S083
Product code: MNQ
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Decision date: 2022-04-07
Decision code: OK30
Date received: 2022-03-15
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Additional lathe equipment to be used to manufacture the terminal pin used in the connector assembly of the Inspire leads, Model 4340 and Model 4063, to increase production capacity.