- Device
- Simplera Sync Sensor, Guardian 4 Sensor
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P250012
- Supplement
- S004
- Product code
- SFI
- Generic name
- Sensor, Glucose, Invasive, Component of automated insulin delivery system
- Decision date
- 2025-10-16
- Decision code
- OK30
- Date received
- 2025-09-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- addition of a new supplier for a critical component of the Guardian Sensor (3) and Guardian 4 Sensor. The Guardian Sensor (3) is a component of the MiniMed 670G, MiniMed 770G, and MiniMed 780G Systems, MiniMed 630G System with Smart Guard, and Guardian Connect Systems. The Guardian 4 Sensor is a component of the MiniMed 780G System