- Device
- FreeStyle Libre 14-Day Flash Glucose Monitoring System
- Applicant
- Abbott Diabetes Care, Inc.
- PMA number
- P160030
- Supplement
- S043
- Product code
- PZE
- Generic name
- Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
- Decision date
- 2020-07-30
- Decision code
- OK30
- Date received
- 2020-07-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- introduction of an alternate supplier for the Sensor Applicator and addition of an inspection step at Abbott Diabetes Care supplier for the sensor component manufacturing process. The Sensor is a component of the FreeStyle Libre Pro Flash Glucose Monitoring System and Freestyle Libre Flash Glucose Monitoring System