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.
Adding a new press, two new molds and a new quality control measurement system at the contract manufacturer. The changes will apply to the enlite sensor and guardian sensor (3) which are part of the minimed 530g, minimed 630g, paradigm real-time revel, ipro2 cgm, and medtronic 670g systems.
| Device | MiniMed 670G System |
| Classification Name | Automated Insulin Dosing Device System, Single Hormonal Control |
| Generic Name | Automated Insulin Dosing Device System, Single Hormonal Control |
| Applicant | MEDTRONIC MINIMED, INC. |
| Date Received | 2018-02-07 |
| Decision Date | 2018-03-09 |
| PMA | P160017 |
| Supplement | S036 |
| Product Code | OZP |
| 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 | MEDTRONIC MINIMED, INC. 18000 Devonshire Street northridge, CA 91325 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160017 | Original Filing | |
| S106 | 2022-11-16 | Special (immediate Track) |
| S105 | 2022-11-04 | 30-day Notice |
| S104 | ||
| S103 | 2022-09-29 | 30-day Notice |
| S102 | 2022-09-14 | Special (immediate Track) |
| S101 | ||
| S100 | 2022-04-01 | 30-day Notice |
| S099 | 2022-03-30 | 30-day Notice |
| S098 | 2022-03-29 | 30-day Notice |
| S097 | ||
| S096 | ||
| S095 | 2021-11-17 | Special (immediate Track) |
| S094 | 2021-09-20 | 30-day Notice |
| S093 | ||
| S092 | 2021-06-29 | 30-day Notice |
| S091 | ||
| S090 | 2021-01-27 | Special (immediate Track) |
| S089 | ||
| S088 | 2020-11-03 | 30-day Notice |
| S087 | 2020-08-28 | Real-time Process |
| S086 | 2020-08-04 | 30-day Notice |
| S085 | 2020-05-26 | 30-day Notice |
| S084 | ||
| S083 | ||
| S082 | 2020-03-30 | 30-day Notice |
| S081 | 2020-01-08 | 30-day Notice |
| S080 | 2019-12-23 | 30-day Notice |
| S079 | 2019-11-29 | 30-day Notice |
| S078 | 2019-11-27 | 30-day Notice |
| S077 | 2019-11-27 | 30-day Notice |
| S076 | ||
| S075 | 2019-10-17 | 30-day Notice |
| S074 | 2019-10-11 | 30-day Notice |
| S073 | 2019-09-30 | 30-day Notice |
| S072 | ||
| S071 | ||
| S070 | 2019-08-21 | 30-day Notice |
| S069 | 2019-07-15 | 30-day Notice |
| S068 | ||
| S067 | 2019-06-19 | 30-day Notice |
| S066 | 2019-06-13 | 30-day Notice |
| S065 | 2019-05-21 | 30-day Notice |
| S064 | 2019-05-17 | 30-day Notice |
| S063 | ||
| S062 | ||
| S061 | ||
| S060 | 2019-04-03 | 30-day Notice |
| S059 | 2019-04-01 | 30-day Notice |
| S058 | 2019-02-25 | 30-day Notice |
| S057 | 2019-02-11 | 30-day Notice |
| S056 | ||
| S055 | 2019-02-01 | 30-day Notice |
| S054 | 2019-01-22 | 30-day Notice |
| S053 | 2018-11-02 | 30-day Notice |
| S052 | 2018-10-15 | 30-day Notice |
| S051 | 2018-08-31 | Real-time Process |
| S050 | 2018-08-07 | Normal 180 Day Track No User Fee |
| S049 | 2018-07-23 | 30-day Notice |
| S048 | 2018-07-23 | Normal 180 Day Track |
| S047 | 2018-07-09 | 30-day Notice |
| S046 | 2018-07-02 | 30-day Notice |
| S045 | 2018-06-19 | 30-day Notice |
| S044 | 2018-06-07 | Special (immediate Track) |
| S043 | 2018-06-04 | 30-day Notice |
| S042 | 2018-05-11 | 30-day Notice |
| S041 | 2018-03-29 | 30-day Notice |
| S040 | 2018-03-26 | 30-day Notice |
| S039 | 2018-03-12 | 30-day Notice |
| S038 | 2018-02-23 | 30-day Notice |
| S037 | 2018-02-09 | Real-time Process |
| S036 | 2018-02-07 | 30-day Notice |
| S035 | 2018-01-31 | 30-day Notice |
| S034 | 2018-01-30 | 30-day Notice |
| S033 | 2018-01-29 | 30-day Notice |
| S032 | 2018-01-29 | 30-day Notice |
| S031 | 2018-01-26 | Panel Track |
| S030 | 2018-01-23 | Special (immediate Track) |
| S029 | 2017-12-22 | 30-day Notice |
| S028 | 2017-11-30 | Real-time Process |
| S027 | 2017-11-24 | Normal 180 Day Track No User Fee |
| S026 | 2017-11-24 | 30-day Notice |
| S025 | ||
| S024 | 2017-10-10 | 30-day Notice |
| S023 | 2017-10-06 | 30-day Notice |
| S022 | ||
| S021 | 2017-09-29 | 30-day Notice |
| S020 | 2017-09-27 | Normal 180 Day Track |
| S019 | 2017-09-14 | 30-day Notice |
| S018 | 2017-08-04 | Real-time Process |
| S017 | 2017-08-02 | Panel Track |
| S016 | 2017-07-21 | Real-time Process |
| S015 | ||
| S014 | 2017-06-02 | Special (immediate Track) |
| S013 | 2017-05-08 | 30-day Notice |
| S012 | 2017-04-10 | 30-day Notice |
| S011 | 2017-03-31 | 30-day Notice |
| S010 | 2017-03-24 | 30-day Notice |
| S009 | ||
| S008 | 2016-12-30 | Real-time Process |
| S007 | 2016-11-28 | 30-day Notice |
| S006 | 2016-11-28 | 30-day Notice |
| S005 | 2016-11-02 | 30-day Notice |
| S004 | 2016-10-27 | Normal 180 Day Track No User Fee |
| S003 | 2016-10-26 | Normal 180 Day Track |
| S002 | 2016-10-14 | 30-day Notice |
| S001 | 2016-10-12 | 30-day Notice |