PMA P160030S010
- Device
- Freestyle Libre Flash Glucose Monitoring System; FreeStyle Libre 14 Day Flash Glucose Monitoring System
- Applicant
- Abbott Diabetes Care, Inc.
- PMA number
- P160030
- Supplement
- S010
- Product code
- PZE
- Decision date
- 2018-10-31
- 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 the addition of the FreeStyle LibreLink App (iOS) as a compatible reading device and alternative primary display for the FreeStyle Libre and Freestyle Libre 14 Day Systems.
Current openFDA PMA Record#
- Device
- Freestyle Libre Flash Glucose Monitoring System; FreeStyle Libre 14 Day Flash Glucose Monitoring System
- Applicant
- Abbott Diabetes Care, Inc.
- PMA number
- P160030
- Supplement
- S010
- Product code
- PZE
- Generic name
- Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
- Decision date
- 2018-10-31
- Decision code
- APPR
- Date received
- 2018-02-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the addition of the FreeStyle LibreLink App (iOS) as a compatible reading device and alternative primary display for the FreeStyle Libre and Freestyle Libre 14 Day Systems.