- Device
- Simplera System
- Applicant
- Medtronic Minimed
- PMA number
- P160007
- Supplement
- S059
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2025-12-08
- Decision code
- OK30
- Date received
- 2025-11-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to the patch bonding equipment 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