- Device
- Inspire Silicone Stimulation Lead, Inspire Silicone Sensing Lead
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S084
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2022-06-16
- Decision code
- OK30
- Date received
- 2022-05-20
- 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 and additional lathe equipment to be used to manufacture the terminal pin used in the connector assembly of the leads for the Inspire Models 4340 and 4063 Respiratory Sensing Leads