Approval for the freestyle libre flash glucose monitoring system. The freestyle libre flash glucose monitoring system is a continuous glucose monitoring (cgm) device indicated for the management of diabetes in persons age 18 and older. It is designed to replace blood glucose testing for diabetes treatment decisions. The system detects trends and tracks patterns aiding in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the system readings should be based on the glucose trends and several sequential readings over time. The system is intended for single patient use and requires a prescription.
| Device | Freestyle Libre Flash Glucose Monitoring System |
| Classification Name | Sensor, Glucose, Invasive, Non-adjunctive, Factory-calibrated, User-initiated |
| Generic Name | Sensor, Glucose, Invasive, Non-adjunctive, Factory-calibrated, User-initiated |
| Applicant | ABBOTT DIABETES CARE INC. |
| Date Received | 2016-08-01 |
| Decision Date | 2017-09-27 |
| Notice Date | 2017-09-29 |
| PMA | P160030 |
| Supplement | S |
| Product Code | PZE |
| Docket Number | 17M-5969 |
| Advisory Committee | Clinical Chemistry |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT DIABETES CARE INC. 1360 South Loop Dr. alameda, CA 94502-7000 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P160030 | | Original Filing |
| S052 |
2022-12-19 |
Normal 180 Day Track No User Fee |
| S051 |
2022-04-01 |
30-day Notice |
| S050 |
2022-02-18 |
30-day Notice |
| S049 |
2022-02-01 |
30-day Notice |
| S048 |
2021-12-20 |
Normal 180 Day Track No User Fee |
| S047 |
2021-02-23 |
Real-time Process |
| S046 |
2020-12-11 |
30-day Notice |
| S045 |
2020-11-27 |
30-day Notice |
| S044 | | |
| S043 |
2020-07-01 |
30-day Notice |
| S042 |
2020-04-01 |
Normal 180 Day Track No User Fee |
| S041 |
2020-03-20 |
30-day Notice |
| S040 |
2019-11-20 |
30-day Notice |
| S039 | | |
| S038 |
2019-08-15 |
30-day Notice |
| S037 |
2019-07-18 |
30-day Notice |
| S036 |
2019-07-12 |
30-day Notice |
| S035 |
2019-05-30 |
30-day Notice |
| S034 | | |
| S033 |
2019-04-10 |
30-day Notice |
| S032 |
2019-02-04 |
30-day Notice |
| S031 | | |
| S030 | | |
| S029 |
2018-12-03 |
Real-time Process |
| S028 |
2018-10-31 |
Normal 180 Day Track |
| S027 |
2018-09-27 |
Normal 180 Day Track |
| S026 |
2018-08-20 |
30-day Notice |
| S025 |
2018-08-09 |
Normal 180 Day Track No User Fee |
| S024 |
2018-07-23 |
30-day Notice |
| S023 |
2018-06-18 |
Real-time Process |
| S022 |
2018-06-08 |
30-day Notice |
| S021 | | |
| S020 |
2018-05-29 |
30-day Notice |
| S019 |
2018-05-01 |
30-day Notice |
| S018 |
2018-05-01 |
Real-time Process |
| S017 |
2018-04-10 |
Panel Track |
| S016 |
2018-03-29 |
30-day Notice |
| S015 |
2018-03-19 |
30-day Notice |
| S014 |
2018-03-12 |
Normal 180 Day Track |
| S013 |
2018-03-05 |
30-day Notice |
| S012 |
2018-03-01 |
30-day Notice |
| S011 |
2018-03-01 |
30-day Notice |
| S010 |
2018-02-26 |
Normal 180 Day Track |
| S009 | | |
| S008 |
2017-12-01 |
30-day Notice |
| S007 |
2017-12-01 |
Real-time Process |
| S006 |
2017-12-01 |
30-day Notice |
| S005 |
2017-11-27 |
30-day Notice |
| S004 |
2017-11-27 |
30-day Notice |
| S003 |
2017-11-20 |
30-day Notice |
| S002 |
2017-11-01 |
30-day Notice |
| S001 |
2017-10-20 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices