- Device
- Medtronic MiniMed 670G System, GS3 Transfer to MPROC, Medtronic MiniMed 770G System, Medtronic MiniMed 780G System
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S105
- Decision date
- 2022-12-08
- Decision code
- OK30
- Date received
- 2022-11-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new supplier for the thermoformed packaging tray for the Enlite sensor and the Guardian Sensor (3). The Enlite sensor is a components of the MiniMed 530G, 630G, Paradigm Real-Time Revel, and iPro2 CGM systems. The Guardian Sensor (3) is a component of the MiniMed 630G, Guardian Connect, 670G and 770G systems.