- Device
- Freestyle Libre 14-Day Flash Glucose Monitoring System
- Applicant
- Abbott Diabetes Care, Inc.
- PMA number
- P160030
- Supplement
- S044
- Product code
- PZE
- Generic name
- Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
- Decision date
- 2021-11-19
- Decision code
- APPR
- Date received
- 2020-08-03
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to introduce a new ISO 8 clean room and associated manufacturing equipment to perform sensor component manufacturing at the ADC Witney, UK manufacturing site. The sensor is a component of the FreeStyle Libre 14-day and FreeStyle Libre Pro Flash Glucose Monitoring Systems