PMA P150021S037
- Device
- FreeStyle Libre Pro Flash Glucose Monitoring System
- Applicant
- Abbott Diabetes Care, Inc.
- PMA number
- P150021
- Supplement
- S037
- Product code
- MDS
- Decision date
- 2019-02-26
- Classification
- Sensor, Glucose, Invasive
- Generic name
- Sensor, glucose, invasive
- Approval order statement
- Approval for a change to the Printed Circuit Board Assembly (PCBA) Battery Contact for the sensor puck assembly.
Current openFDA PMA Record#
- Device
- FreeStyle Libre Pro Flash Glucose Monitoring System
- Applicant
- Abbott Diabetes Care, Inc.
- PMA number
- P150021
- Supplement
- S037
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2019-02-26
- Decision code
- APPR
- Date received
- 2018-12-03
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change to the Printed Circuit Board Assembly (PCBA) Battery Contact for the sensor puck assembly.