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 Pro Flash Glucose Monitoring System |
| Generic Name | Sensor, Glucose, Invasive |
| Applicant | Abbott Diabetes Care Inc.1360 South Loop Rd.alameda, CA 94502 PMA NumberP150021 Supplement NumberS057 Date Received04/01/2022 Decision Date04/28/2022 Product Code MDS Advisory Committee Clinical Chemistry Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-04-01 |
| Decision Date | 2022-04-28 |
| PMA | P150021 |
| Supplement | S057 |
| Product Code | MDS |
| 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 Rd. alameda, CA 94502 PMA NumberP150021 Supplement NumberS057 Date Received04/01/2022 Decision Date04/28/2022 Product Code MDS Advisory Committee Clinical Chemistry Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement approval To Update An Analytical Method Used To Evaluate A Raw Ingredient Of The Glucose Sensor Component And To Introduce The Evaluation Process To An Additional Manufacturing Site. The Glucose Sensor Is A Component Of The FreeStyle Libre 14-Day And FreeStyle Libre Pro Glucose Monitoring Systems |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 30357599716876 | P150021 | 000 |
| 30357599715626 | P150021 | 000 |
| 30357599715619 | P150021 | 000 |
| 57599-0715-55 | P150021 | 000 |
| 30357599000418 | P150021 | 000 |