PMA P130008

Device: Inspire Model 4063 Leads; Inspire Model 4340 Leads
Applicant: Inspire Medical Systems
PMA number: P130008
Supplement: S093
Product code: MNQ
Decision date: 2026-05-28
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Approval order statement: approval for additional EO sterilization chambers (Chambers 02 and 21) at the current validated sterilization vendor, Steris Applied Sterilization Technologies (AST), for the Model 4063 Stimulation Lead and Model 4340 Sensing Lead

Current openFDA PMA Record#

Device: Inspire Model 4063 Leads; Inspire Model 4340 Leads
Applicant: Inspire Medical Systems
PMA number: P130008
Supplement: S139
Product code: MNQ
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Decision date: 2026-05-28
Decision code: OK30
Date received: 2026-04-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for additional EO sterilization chambers (Chambers 02 and 21) at the current validated sterilization vendor, Steris Applied Sterilization Technologies (AST), for the Model 4063 Stimulation Lead and Model 4340 Sensing Lead