Changes to the molding process parameters and molding equipment used for the plastic component which houses the sensor introducer needle in the sensor applicator for the freestyle libre pro flash glucose monitoring system.
| Device | Freestyle Libre Pro Flash Glucose Monitoring System |
| Classification Name | Sensor, Glucose, Invasive |
| Generic Name | Sensor, Glucose, Invasive |
| Applicant | Abbott Diabetes Care Inc. |
| Date Received | 2017-06-12 |
| Decision Date | 2017-07-12 |
| PMA | P150021 |
| Supplement | S010 |
| 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 |
Supplemental Filings
| 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 |
NIH GUDID Devices