- Device
- FreeStyle Libre Pro Flash Glucose Monitoring System
- Applicant
- Abbott Diabetes Care, Inc.
- PMA number
- P150021
- Supplement
- S052
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2021-01-05
- Decision code
- OK30
- Date received
- 2020-12-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introducing an alternate higher cavitation mold tooling and injection molding machine 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.