- Device
- FreeStyle Libre Pro Flash Glucose Monitoring System
- Applicant
- Abbott Diabetes Care, Inc.
- PMA number
- P150021
- Supplement
- S056
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2022-03-16
- Decision code
- OK30
- Date received
- 2022-02-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a manufacturing site for the manufacture of a sensor electrode material. The sensor is a component of the FreeStyle Libre Pro Flash Glucose Monitoring System and Freestyle Libre 14-Day Flash Glucose Monitoring System.