PMA P150021S038
- Device
- Freestyle Libre Pro Flash Glucose Monitoring System
- Applicant
- Abbott Diabetes Care, Inc.
- PMA number
- P150021
- Supplement
- S038
- Product code
- MDS
- Decision date
- 2019-03-19
- Classification
- Sensor, Glucose, Invasive
- Generic name
- Sensor, glucose, invasive
- Approval order statement
- Approval for design changes to improve drop, vibration, and shock resistance to the Freestyle Libre Pro Reader.
Current openFDA PMA Record#
- Device
- Freestyle Libre Pro Flash Glucose Monitoring System
- Applicant
- Abbott Diabetes Care, Inc.
- PMA number
- P150021
- Supplement
- S038
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2019-03-19
- Decision code
- APPR
- Date received
- 2018-12-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for design changes to improve drop, vibration, and shock resistance to the Freestyle Libre Pro Reader.