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 NumberS049 Date Received02/01/2022 Decision Date03/02/2022 Product Code PZE Advisory Committee Clinical Chemistry Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-02-01 |
| Decision Date | 2022-03-02 |
| PMA | P160030 |
| Supplement | S049 |
| 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 PMA NumberP160030 Supplement NumberS049 Date Received02/01/2022 Decision Date03/02/2022 Product Code PZE 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 For Addition Of An Alternate Manufacturing Site For The Manufacture Of A Sensor Membrane Polymer Component. The Sensor Is A Component Of The FreeStyle Libre Pro Flash Glucose Monitoring System And Freestyle Libre Flash Glucose Monitoring System |
| 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 |