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.
Approval for adding the upper arm as an alternate insertion site for the guardian sensor (3).
| 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 | 2017-08-02 |
| Decision Date | 2018-02-13 |
| Notice Date | 2018-03-14 |
| PMA | P160017 |
| Supplement | S017 |
| Product Code | OZP |
| Docket Number | 18M-0738 |
| Advisory Committee | Clinical Chemistry |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDTRONIC MINIMED, INC. 18000 Devonshire Street northridge, CA 91325 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| 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 |