- Device
- FreeStyle Libre Pro Flash Glucose Monitoring System
- Applicant
- Abbott Diabetes Care, Inc.
- PMA number
- P150021
- Supplement
- S054
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2021-09-30
- Decision code
- OK30
- Date received
- 2021-09-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an alternate manufacturing site for sensor container assembly and finished sensor kit packing. The sensor container and sensor kit are components of the FreeStyle Libre Pro Flash continuous glucose monitoring (CGM) device