This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the minimed 5300 system. This device is indicated for the following:minimed 530g system - the minimed 530g system is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for themanagement of diabetes mellitus in persons, sixteen years of age and older, requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The minimed 530g system can be programmed to automatically suspend delivery of insulin when the sensor glucose value falls below a predefined threshold value. For additional information please refer to approval order.
| Device | MINIMED 530G SYSTEM |
| Classification Name | Automated Insulin Dosing , Threshold Suspend |
| Generic Name | Automated Insulin Dosing , Threshold Suspend |
| Applicant | MEDTRONIC Inc. |
| Date Received | 2012-06-05 |
| Decision Date | 2013-09-26 |
| Notice Date | 2013-09-30 |
| PMA | P120010 |
| Supplement | S |
| Product Code | OZO |
| Docket Number | 13M-1206 |
| Advisory Committee | Clinical Chemistry |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | MEDTRONIC Inc. 18000 Devonshire Street northridge, CA 91325-1219 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |