- Device
- FreeStyle Libre 14-Day Flash Glucose Monitoring System
- Applicant
- Abbott Diabetes Care, Inc.
- PMA number
- P160030
- Supplement
- S057
- Product code
- PZE
- Generic name
- Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
- Decision date
- 2025-07-11
- Decision code
- OK30
- Date received
- 2025-06-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the implementation of updated software for a quality control process used for internally releasing components for manufacturing of the FreeStyle Libre Pro Flash and FreeStyle Libre 14-Day Flash Glucose Monitoring Systems