This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | FreeStyle Libre 14-day Flash Glucose Monitoring System |
| Generic Name | Sensor, Glucose, Invasive, Non-adjunctive, Factory-calibrated, User-initiated |
| Applicant | ABBOTT DIABETES CARE INC.1360 South Loop Dr.alameda, CA 94502-7000 PMA NumberP160030 Supplement NumberS052 Date Received12/19/2022 Decision Date01/17/2023 Product Code PZE Advisory Committee Clinical Chemistry Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No |
| Date Received | 2022-12-19 |
| Decision Date | 2023-01-17 |
| PMA | P160030 |
| Supplement | S052 |
| Product Code | PZE |
| Advisory Committee | Clinical Chemistry |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT DIABETES CARE INC. 1360 South Loop Dr. alameda, CA 94502-7000 PMA NumberP160030 Supplement NumberS052 Date Received12/19/2022 Decision Date01/17/2023 Product Code PZE Advisory Committee Clinical Chemistry Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval Of The Revised Protocol For The Post-approval Study. |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 30357599000197 | P160030 | 000 |
| 30357599000852 | P160030 | 000 |
| 30357599000241 | P160030 | 000 |
| 30357599000227 | P160030 | 000 |
| 30357599000210 | P160030 | 000 |
| 30357599000203 | P160030 | 000 |
| 00357599000059 | P160030 | 010 |
| 57599-0002-00 | P160030 | 017 |
| 30357599000982 | P160030 | 017 |
| 30357599000975 | P160030 | 017 |
| 30357599002009 | P160030 | 017 |
| 30357599001026 | P160030 | 017 |
| 30357599001019 | P160030 | 017 |
| 57599-0000-97 | P160030 | 017 |
| 00357599000042 | P160030 | 031 |