PMA P160030S052
- Device
- FreeStyle Libre 14-day Flash Glucose Monitoring System
- Applicant
- Abbott Diabetes Care, Inc.
- PMA number
- P160030
- Supplement
- S052
- Product code
- PZE
- Decision date
- 2023-01-17
- Generic name
- Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
- Approval order statement
- Approval of the revised protocol for the post-approval study.
Current openFDA PMA Record#
- Device
- FreeStyle Libre 14-day Flash Glucose Monitoring System
- Applicant
- Abbott Diabetes Care, Inc.
- PMA number
- P160030
- Supplement
- S052
- Product code
- PZE
- Generic name
- Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
- Decision date
- 2023-01-17
- Decision code
- APPR
- Date received
- 2022-12-19
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study.