PMA P130008S081

Device: Inspire Model 4340 Respiratory Sensing Lead
Applicant: Inspire Medical Systems
PMA number: P130008
Supplement: S081
Product code: MNQ
Decision date: 2022-03-14
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Approval order statement: Notification of replacing obsolete Metal- Oxide- Semiconductor Field-Effect Transistor (MOSFET) for the Sensor Assembly in the Inspire Model 4340 Respiratory Sensing Lead.

Current openFDA PMA Record#

Device: Inspire Model 4340 Respiratory Sensing Lead
Applicant: Inspire Medical Systems
PMA number: P130008
Supplement: S081
Product code: MNQ
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Decision date: 2022-03-14
Decision code: OK30
Date received: 2022-02-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Notification of replacing obsolete Metal- Oxide- Semiconductor Field-Effect Transistor (MOSFET) for the Sensor Assembly in the Inspire Model 4340 Respiratory Sensing Lead.