- Device
- FreeStyle Libre Pro Flash Glucose Monitoring System
- Applicant
- Abbott Diabetes Care, Inc.
- PMA number
- P150021
- Supplement
- S053
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2021-09-01
- Decision code
- APPR
- Date received
- 2021-02-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval of a change in the membrane layer polymer of the Libre Sensor. The Libre Sensor is a component of the FreeStyle Libre Pro Flash Glucose Monitoring System and Freestyle Libre Flash Glucose Monitoring System.