Approval for an additional manufacturing and assembly line for a component of the freestyle libre sensor pack. The sensor pack is a component of the freestyle libre and freestyle libre pro flash glucose monitoring systems
| Device | FreeStyle Libre 14day 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 | 2019-02-04 |
| Decision Date | 2019-03-04 |
| PMA | P160030 |
| Supplement | S032 |
| Product Code | PZE |
| Advisory Committee | Clinical Chemistry |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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