Approval for design changes to the puck carrier, applicator cap, and container tray of the freestyle libre flash glucose monitoring system and freestyle libre pro flash glucose monitoring system, as well as manufacturing changes in increase production capacity for the same components.
| 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 | 2017-12-01 |
| Decision Date | 2018-02-26 |
| PMA | P150021 |
| Supplement | S016 |
| Product Code | MDS |
| Advisory Committee | Clinical Chemistry |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott Diabetes Care Inc. 1360 South Loop Rd. alameda, CA 94502 |
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