- Device
- Simplera Sync Sensor, Guardian 4 Sensor
- Applicant
- Medtronic Minimed, Inc.
- PMA number
- P250012
- Supplement
- S003
- Product code
- SFI
- Generic name
- Sensor, Glucose, Invasive, Component of automated insulin delivery system
- Decision date
- 2025-09-12
- Decision code
- OK30
- Date received
- 2025-08-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to the patch bonding process of Simplera and Simplera Sync sensors. The Simplera Sensor is a component of the Simplera system. The Simplera Sync sensor is a component of the MiniMed 670G, MiniMed 770G, and MiniMed 780G systems