- Device
- FreeStyle Libre Pro Flash Glucose Monitoring System
- Applicant
- Abbott Diabetes Care, Inc.
- PMA number
- P150021
- Supplement
- S057
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2022-04-28
- Decision code
- OK30
- Date received
- 2022-04-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update an analytical method used to evaluate a raw ingredient of the glucose sensor component and to introduce the evaluation process to an additional manufacturing site. The glucose sensor is a component of the FreeStyle Libre 14-Day and FreeStyle Libre Pro Glucose Monitoring Systems.