- Device
- FreeStyle Libre 14-day Flash Glucose Monitoring System
- Applicant
- Abbott Diabetes Care, Inc.
- PMA number
- P160030
- Supplement
- S041
- Product code
- PZE
- Generic name
- Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
- Decision date
- 2020-04-13
- Decision code
- OK30
- Date received
- 2020-03-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update to the in-process optical setup and image processing for the vision systems that verify three Critical Quality Attributes of the glucose sensor puck. The sensor is a component of the FreeStyle Libre 14-day and FreeStyle Libre Pro Glucose Monitoring System.