- Device
- Guardian Sensor 3, Guardian 4 Sensor
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P160017
- Supplement
- S114
- Product code
- OZP
- Generic name
- Automated insulin dosing device system, single hormonal control
- Decision date
- 2024-01-03
- Decision code
- OK30
- Date received
- 2023-12-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to automate the tray sealing and lid printing process for the Guardian Sensor 3 and the Guardian 4 sensor. The Guardian Sensor 3 is a component of the MiniMed 630G, MiniMed 670G, MiniMed 770G, MiniMed 780G and Guardian Connect systems. The Guardian 4 Sensor is a component of the MiniMed 780G System