- Device
- FreeStyle Libre 14 day Flash Glucose Monitoring System
- Applicant
- Abbott Diabetes Care, Inc.
- PMA number
- P160030
- Supplement
- S055
- Product code
- PZE
- Generic name
- Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
- Decision date
- 2023-11-21
- Decision code
- OK30
- Date received
- 2023-10-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the addition of a verification check to the quality control process used for internally releasing parts for manufacturing of the FreeStyle Libre Pro Flash and FreeStyle Libre 14 day Flash Glucose Monitoring Systems