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 | Guardian Sensor (3) (MMT-7020) |
| Generic Name | Automated Insulin Dosing Device System, Single Hormonal Control |
| Applicant | MEDTRONIC MINIMED, INC.18000 Devonshire Streetnorthridge, CA 91325 PMA NumberP160017 Supplement NumberS100 Date Received04/01/2022 Decision Date04/29/2022 Product Code OZP 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 | 2022-04-29 |
| PMA | P160017 |
| Supplement | S100 |
| 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 PMA NumberP160017 Supplement NumberS100 Date Received04/01/2022 Decision Date04/29/2022 Product Code OZP 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 Bioburden And Sterility Contract Testing Laboratory For The Enlite Sensor And The Guardian Sensor (3). The Enlite Sensor Is A Components Of The MiniMed 530G, 630G, Paradigm Real-Time Revel, And IPro2 CGM Systems. The Guardian Sensor (3) Is A Component Of The MiniMed 630G, Guardian Connect, 670G And 770G Systems |
| 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 |