Approval for alternate electrostatic discharge (esd) suppressor components for the reader of the freestyle libre flash glucose monitoring system and the reader of the freestyle libre pro flash glucose monitoring system, to support higher manufacturing capacity
| 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 | 2018-06-18 |
| Decision Date | 2018-07-03 |
| PMA | P160030 |
| Supplement | S023 |
| Product Code | PZE |
| 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 Dr. alameda, CA 94502-7000 |
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