The freestyle libre pro flash glucose monitoring system is a professional continuous glucose monitoring (cgm) device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes. The system is intended for use by health care professionals and requires a prescription. Readings from the freestyle libre pro sensor are only made available to patients through consultation with a health care professional. The system does not require user calibration with blood glucose values. The freestyle libre pro system aids in the detection of glucose level excursions above or below the desired range, facilitating therapy adjustments. Interpretation of the freestyle libre pro flash glucose monitoring system readings should be based on the trends and patterns analyzed through time using the reports available.
| Device | FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEM |
| Classification Name | Sensor, Glucose, Invasive |
| Generic Name | Sensor, Glucose, Invasive |
| Applicant | Abbott Diabetes Care Inc. |
| Date Received | 2015-06-19 |
| Decision Date | 2016-09-23 |
| Notice Date | 2016-09-26 |
| PMA | P150021 |
| Supplement | S |
| Product Code | MDS |
| Docket Number | 16M-2971 |
| Advisory Committee | Clinical Chemistry |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott Diabetes Care Inc. 1360 South Loop Rd. alameda, CA 94502 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P150021 | | Original Filing |
| S057 |
2022-04-01 |
30-day Notice |
| S056 |
2022-02-18 |
30-day Notice |
| S055 |
2022-02-01 |
30-day Notice |
| S054 |
2021-09-03 |
30-day Notice |
| S053 |
2021-02-23 |
Real-time Process |
| S052 |
2020-12-11 |
30-day Notice |
| S051 |
2020-11-27 |
30-day Notice |
| S050 | | |
| S049 |
2020-07-01 |
30-day Notice |
| S048 |
2020-03-20 |
30-day Notice |
| S047 |
2019-11-20 |
30-day Notice |
| S046 | | |
| S045 |
2019-08-15 |
30-day Notice |
| S044 |
2019-07-18 |
30-day Notice |
| S043 |
2019-07-12 |
30-day Notice |
| S042 |
2019-05-30 |
30-day Notice |
| S041 |
2019-04-10 |
30-day Notice |
| S040 |
2019-02-04 |
30-day Notice |
| S039 | | |
| S038 |
2018-12-26 |
Real-time Process |
| S037 |
2018-12-03 |
Real-time Process |
| S036 |
2018-10-31 |
Normal 180 Day Track |
| S035 |
2018-09-27 |
Normal 180 Day Track |
| S034 |
2018-08-29 |
30-day Notice |
| S033 |
2018-08-20 |
30-day Notice |
| S032 |
2018-07-23 |
30-day Notice |
| S031 |
2018-06-18 |
Real-time Process |
| S030 |
2018-06-08 |
30-day Notice |
| S029 |
2018-05-29 |
30-day Notice |
| S028 |
2018-05-01 |
30-day Notice |
| S027 |
2018-05-01 |
Real-time Process |
| S026 |
2018-03-29 |
30-day Notice |
| S025 |
2018-03-19 |
30-day Notice |
| S024 |
2018-03-12 |
Normal 180 Day Track |
| S023 |
2018-03-05 |
30-day Notice |
| S022 |
2018-03-01 |
30-day Notice |
| S021 |
2018-03-01 |
30-day Notice |
| S020 | | |
| S019 |
2018-01-23 |
30-day Notice |
| S018 |
2018-01-16 |
30-day Notice |
| S017 |
2017-12-01 |
30-day Notice |
| S016 |
2017-12-01 |
Real-time Process |
| S015 |
2017-11-27 |
30-day Notice |
| S014 |
2017-11-27 |
30-day Notice |
| S013 |
2017-11-20 |
30-day Notice |
| S012 |
2017-09-25 |
Normal 180 Day Track No User Fee |
| S011 |
2017-08-02 |
Real-time Process |
| S010 |
2017-06-12 |
30-day Notice |
| S009 |
2017-05-22 |
135 Review Track For 30-day Notice |
| S008 |
2017-05-19 |
135 Review Track For 30-day Notice |
| S007 |
2017-05-02 |
Real-time Process |
| S006 |
2017-04-03 |
Normal 180 Day Track |
| S005 |
2017-03-30 |
30-day Notice |
| S004 |
2016-12-16 |
135 Review Track For 30-day Notice |
| S003 |
2016-12-14 |
30-day Notice |
| S002 | | |
| S001 |
2016-11-01 |
Normal 180 Day Track |
NIH GUDID Devices