PMA supplement
P160030 S048: Freestyle Libre 14 day Flash Glucose Monitoring System
FDA PMA supplement · Normal 180 Day Track No User Fee · Abbott Diabetes Care, Inc.
Key facts
| Original PMA | P160030 |
|---|---|
| Supplement number | S048 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Postapproval Study Protocol |
| Trade name | Freestyle Libre 14 day Flash Glucose Monitoring System |
| Generic name | Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated |
| Applicant | Abbott Diabetes Care, Inc. |
| Product code | PZE |
| Received date | Dec 20, 2021 |
| Decision date | Jan 19, 2022 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: