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 manufacturing changes related to bioburden testing for the enlite sensor and guardian sensor (3). The enlite sensor is component of the minimed 530g system, the minimed 630g system, the paradigm real-time revel system, and the ipro2 cgm system. The guardian sensor (3) is component of the minimed 670g system, the guardian connect system, and the minimed 630g system with smartguard
| Device | MiniMed 530G System |
| Generic Name | Automated Insulin Dosing , Threshold Suspend |
| Applicant | MEDTRONIC Inc. |
| Date Received | 2020-11-03 |
| Decision Date | 2020-12-01 |
| PMA | P120010 |
| Supplement | S138 |
| Product Code | OZO |
| 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 Inc. 18000 Devonshire Street northridge, CA 91325-1219 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P120010 | Original Filing | |
| S142 | 2022-11-04 | 30-day Notice |
| S141 | 2022-04-01 | 30-day Notice |
| S140 | 2021-11-17 | Special (immediate Track) |
| S139 | 2021-01-27 | Special (immediate Track) |
| S138 | 2020-11-03 | 30-day Notice |
| S137 | 2019-11-29 | 30-day Notice |
| S136 | 2019-10-17 | 30-day Notice |
| S135 | 2019-10-11 | 30-day Notice |
| S134 | ||
| S133 | 2019-08-21 | 30-day Notice |
| S132 | 2019-07-15 | 30-day Notice |
| S131 | 2019-06-19 | 30-day Notice |
| S130 | ||
| S129 | 2019-02-11 | 30-day Notice |
| S128 | 2019-02-01 | 30-day Notice |
| S127 | ||
| S126 | 2018-11-07 | 30-day Notice |
| S125 | 2018-11-07 | 30-day Notice |
| S124 | 2018-11-07 | 30-day Notice |
| S123 | 2018-11-02 | 30-day Notice |
| S122 | 2018-10-15 | 30-day Notice |
| S121 | 2018-10-01 | 30-day Notice |
| S120 | 2018-07-16 | 30-day Notice |
| S119 | 2018-07-09 | 30-day Notice |
| S118 | 2018-06-19 | 30-day Notice |
| S117 | 2018-06-07 | Special (immediate Track) |
| S116 | 2018-04-30 | 30-day Notice |
| S115 | 2018-03-26 | 30-day Notice |
| S114 | 2018-03-12 | 30-day Notice |
| S113 | 2018-02-09 | Real-time Process |
| S112 | 2018-02-07 | 30-day Notice |
| S111 | 2018-01-29 | 30-day Notice |
| S110 | 2018-01-29 | 30-day Notice |
| S109 | 2017-12-22 | 30-day Notice |
| S108 | 2017-12-20 | Real-time Process |
| S107 | 2017-11-24 | 30-day Notice |
| S106 | 2017-10-30 | 30-day Notice |
| S105 | 2017-07-17 | 30-day Notice |
| S104 | 2017-05-30 | 30-day Notice |
| S103 | 2017-04-10 | 30-day Notice |
| S102 | 2017-03-31 | 30-day Notice |
| S101 | 2017-02-03 | Normal 180 Day Track No User Fee |
| S100 | 2016-12-23 | Real-time Process |
| S099 | 2016-11-28 | 30-day Notice |
| S098 | 2016-11-28 | 30-day Notice |
| S097 | 2016-11-02 | 30-day Notice |
| S096 | ||
| S095 | 2016-09-19 | 30-day Notice |
| S094 | ||
| S093 | 2016-07-26 | 30-day Notice |
| S092 | 2016-07-21 | 30-day Notice |
| S091 | 2016-06-15 | 135 Review Track For 30-day Notice |
| S090 | ||
| S089 | 2016-04-27 | 135 Review Track For 30-day Notice |
| S088 | 2016-03-28 | 30-day Notice |
| S087 | 2016-03-25 | 30-day Notice |
| S086 | 2016-03-25 | 30-day Notice |
| S085 | 2016-03-09 | 30-day Notice |
| S084 | 2016-03-07 | 30-day Notice |
| S083 | 2016-02-23 | 30-day Notice |
| S082 | 2015-12-28 | 30-day Notice |
| S081 | 2015-12-15 | 30-day Notice |
| S080 | 2015-11-27 | 30-day Notice |
| S079 | 2015-11-09 | 30-day Notice |
| S078 | 2015-11-09 | 30-day Notice |
| S077 | 2015-11-09 | 30-day Notice |
| S076 | 2015-11-03 | 135 Review Track For 30-day Notice |
| S075 | 2015-11-03 | 30-day Notice |
| S074 | 2015-11-02 | Real-time Process |
| S073 | 2015-10-19 | 30-day Notice |
| S072 | 2015-08-10 | 135 Review Track For 30-day Notice |
| S071 | 2015-07-20 | Normal 180 Day Track No User Fee |
| S070 | 2015-06-09 | Normal 180 Day Track |
| S069 | 2015-05-29 | 30-day Notice |
| S068 | 2015-05-01 | 135 Review Track For 30-day Notice |
| S067 | 2015-04-29 | Real-time Process |
| S066 | 2015-04-20 | 30-day Notice |
| S065 | 2015-03-18 | 30-day Notice |
| S064 | 2015-03-10 | 135 Review Track For 30-day Notice |
| S063 | 2015-02-26 | 30-day Notice |
| S062 | 2015-02-18 | Real-time Process |
| S061 | 2015-02-06 | Real-time Process |
| S060 | 2015-01-30 | 30-day Notice |
| S059 | 2015-01-28 | 30-day Notice |
| S058 | 2015-01-26 | 135 Review Track For 30-day Notice |
| S057 | 2015-01-26 | 30-day Notice |
| S056 | 2015-01-06 | Real-time Process |
| S055 | 2014-12-31 | 30-day Notice |
| S054 | 2014-12-30 | Real-time Process |
| S053 | 2014-12-30 | 30-day Notice |
| S052 | 2015-02-17 | Normal 180 Day Track |
| S051 | 2014-12-15 | 30-day Notice |
| S050 | 2014-12-10 | 30-day Notice |
| S049 | 2014-12-04 | 30-day Notice |
| S048 | 2014-12-02 | 30-day Notice |
| S047 | 2014-11-26 | 30-day Notice |
| S046 | 2014-12-10 | Panel Track |
| S045 | 2014-11-04 | 30-day Notice |
| S044 | ||
| S043 | 2014-11-03 | 30-day Notice |
| S042 | 2014-10-31 | Real-time Process |
| S041 | 2014-10-30 | Real-time Process |
| S040 | 2014-10-30 | 135 Review Track For 30-day Notice |
| S039 | 2014-10-27 | 30-day Notice |
| S038 | 2014-10-22 | 30-day Notice |
| S037 | 2014-10-20 | 30-day Notice |
| S036 | 2014-09-22 | Real-time Process |
| S035 | 2014-09-05 | 30-day Notice |
| S034 | 2014-09-04 | 30-day Notice |
| S033 | 2014-08-11 | 135 Review Track For 30-day Notice |
| S032 | 2014-08-01 | Normal 180 Day Track No User Fee |
| S031 | 2014-07-29 | 30-day Notice |
| S030 | 2014-07-07 | Real-time Process |
| S029 | 2014-07-11 | Normal 180 Day Track |
| S028 | 2014-06-24 | 30-day Notice |
| S027 | 2014-06-23 | 30-day Notice |
| S026 | 2014-06-23 | Real-time Process |
| S025 | 2014-06-03 | 30-day Notice |
| S024 | 2014-06-02 | Real-time Process |
| S023 | 2014-04-29 | 135 Review Track For 30-day Notice |
| S022 | 2014-04-14 | 30-day Notice |
| S021 | 2014-04-11 | Real-time Process |
| S020 | 2014-04-11 | 30-day Notice |
| S019 | 2014-03-21 | Real-time Process |
| S018 | ||
| S017 | 2014-03-10 | 30-day Notice |
| S016 | 2014-03-06 | Real-time Process |
| S015 | 2014-03-04 | 30-day Notice |
| S014 | 2014-03-04 | 30-day Notice |
| S013 | 2014-02-24 | 30-day Notice |
| S012 | 2014-02-20 | 30-day Notice |
| S011 | 2014-02-18 | 30-day Notice |
| S010 | 2014-02-06 | 30-day Notice |
| S009 | 2014-01-28 | 30-day Notice |
| S008 | 2013-12-23 | Real-time Process |
| S007 | ||
| S006 | 2013-11-08 | 30-day Notice |
| S005 | 2013-11-08 | 135 Review Track For 30-day Notice |
| S004 | 2013-11-08 | 135 Review Track For 30-day Notice |
| S003 | 2013-11-07 | 135 Review Track For 30-day Notice |
| S002 | 2013-11-07 | Special (immediate Track) |
| S001 | 2013-11-06 | 135 Review Track For 30-day Notice |