PMA P160030S029
- Device
- Freestyle Libre Flash Glucose Monitoring System
- Applicant
- Abbott Diabetes Care, Inc.
- PMA number
- P160030
- Supplement
- S029
- Product code
- PZE
- Decision date
- 2019-02-26
- Classification
- Sensor, Glucose, Invasive, Non-adjunctive, Factory-calibrated, User-initiated
- Generic name
- Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
- 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 Flash Glucose Monitoring System
- Applicant
- Abbott Diabetes Care, Inc.
- PMA number
- P160030
- Supplement
- S029
- Product code
- PZE
- Generic name
- Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
- 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.