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 the paradigm real-time and guardian real-time systems. The guardian real-time system is indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adults, age 18 and over, and in children and adolescents, age 7 to 17, with diabetes mellitus, for the purpose of improving diabetes management. It alerts if a glucose level falls below, or rises above, preset values. Values are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a fingerstick may be required. All therapy adjustments should be based on measurements obtained using a home glucose monitor. The system provides real-time glucose values that allow users to track patterns in glucose concentrations and to possibly identify episodes of low and high blood glucose. It also stores the data so that it can be analyzed to track patterns. Glucose data can be further downloaded to pc software for analysis of historical glucose values. The paradigm real-time system is indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, and possible low and high blood glucose episodes in adults, age 18 and over, and in children and adolescents, age 7 through 17. The system provides an alert if glucose levels fall below or rise above preset values. Glucose values provided by the system are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a fingerstick may be required. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not on sensor glucose readings provided by the paradigm real-time system.
| Device | GUARDIAN REAL-TIME AND PARADIGM REAL-TIME SYSTEMS |
| Classification Name | Sensor, Glucose, Invasive |
| Generic Name | Sensor, Glucose, Invasive |
| Applicant | MEDTRONIC MINIMED |
| Date Received | 2006-02-27 |
| Decision Date | 2007-03-08 |
| Notice Date | 2007-03-26 |
| PMA | P980022 |
| Supplement | S015 |
| Product Code | MDS |
| Docket Number | 07M-0107 |
| Advisory Committee | Clinical Chemistry |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | MEDTRONIC MINIMED 18000 Devonshire St northridge, CA 91325 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P980022 | Original Filing | |
| S208 | 2019-07-15 | 30-day Notice |
| S207 | 2018-11-07 | 30-day Notice |
| S206 | 2018-10-01 | 30-day Notice |
| S205 | 2018-07-16 | 30-day Notice |
| S204 | 2018-04-30 | 30-day Notice |
| S203 | 2018-01-29 | 30-day Notice |
| S202 | 2018-01-29 | 30-day Notice |
| S201 | 2017-12-20 | Real-time Process |
| S200 | 2017-06-22 | Real-time Process |
| S199 | 2017-04-10 | 30-day Notice |
| S198 | ||
| S197 | 2016-11-28 | 30-day Notice |
| S196 | ||
| S195 | 2016-09-19 | 30-day Notice |
| S194 | ||
| S193 | 2016-07-26 | 30-day Notice |
| S192 | ||
| S191 | 2016-03-25 | 30-day Notice |
| S190 | 2016-03-07 | 30-day Notice |
| S189 | 2015-11-27 | 30-day Notice |
| S188 | 2015-11-09 | 30-day Notice |
| S187 | 2015-11-09 | 30-day Notice |
| S186 | 2015-11-09 | 30-day Notice |
| S185 | ||
| S184 | 2015-11-04 | 30-day Notice |
| S183 | 2015-11-03 | 135 Review Track For 30-day Notice |
| S182 | 2015-11-03 | 30-day Notice |
| S181 | 2015-11-02 | Real-time Process |
| S180 | 2015-03-18 | 30-day Notice |
| S179 | 2015-03-10 | 135 Review Track For 30-day Notice |
| S178 | 2015-02-18 | Real-time Process |
| S177 | 2014-12-30 | Real-time Process |
| S176 | 2015-02-17 | Normal 180 Day Track |
| S175 | 2014-12-15 | 30-day Notice |
| S174 | 2014-12-04 | 30-day Notice |
| S173 | 2014-11-26 | 30-day Notice |
| S172 | 2014-11-05 | 30-day Notice |
| S171 | 2014-11-03 | 30-day Notice |
| S170 | 2014-11-03 | 30-day Notice |
| S169 | 2014-10-31 | 30-day Notice |
| S168 | 2014-10-31 | Real-time Process |
| S167 | 2014-10-31 | Real-time Process |
| S166 | 2014-10-30 | 135 Review Track For 30-day Notice |
| S165 | 2014-10-27 | 30-day Notice |
| S164 | 2014-10-21 | 30-day Notice |
| S163 | 2014-10-20 | 30-day Notice |
| S162 | 2014-10-17 | 30-day Notice |
| S161 | 2014-09-22 | Real-time Process |
| S160 | 2014-08-11 | 135 Review Track For 30-day Notice |
| S159 | 2014-07-11 | Normal 180 Day Track |
| S158 | 2014-06-23 | 30-day Notice |
| S157 | 2014-06-18 | 30-day Notice |
| S156 | 2014-04-29 | 135 Review Track For 30-day Notice |
| S155 | 2014-04-14 | 30-day Notice |
| S154 | 2014-04-11 | Real-time Process |
| S153 | 2014-03-18 | Real-time Process |
| S152 | ||
| S151 | 2014-01-28 | 30-day Notice |
| S150 | 2013-12-23 | Real-time Process |
| S149 | 2013-11-29 | Special (immediate Track) |
| S148 | 2013-11-08 | 30-day Notice |
| S147 | 2013-11-08 | 135 Review Track For 30-day Notice |
| S146 | 2013-11-08 | 135 Review Track For 30-day Notice |
| S145 | 2013-11-08 | 30-day Notice |
| S144 | ||
| S143 | 2013-11-07 | 135 Review Track For 30-day Notice |
| S142 | 2013-11-07 | Special (immediate Track) |
| S141 | ||
| S140 | 2013-11-06 | 135 Review Track For 30-day Notice |
| S139 | ||
| S138 | 2013-10-03 | Special (immediate Track) |
| S137 | 2013-08-27 | 30-day Notice |
| S136 | 2013-08-23 | Special (immediate Track) |
| S135 | 2013-07-24 | Special (immediate Track) |
| S134 | 2013-04-10 | Real-time Process |
| S133 | 2013-02-22 | Normal 180 Day Track |
| S132 | 2013-02-06 | 30-day Notice |
| S131 | 2013-01-28 | Real-time Process |
| S130 | 2012-12-03 | 135 Review Track For 30-day Notice |
| S129 | 2012-11-15 | Real-time Process |
| S128 | 2012-11-14 | Real-time Process |
| S127 | 2012-11-13 | 135 Review Track For 30-day Notice |
| S126 | 2012-11-09 | 135 Review Track For 30-day Notice |
| S125 | 2012-10-31 | Real-time Process |
| S124 | 2012-09-18 | Real-time Process |
| S123 | 2012-08-30 | Real-time Process |
| S122 | 2012-08-23 | 30-day Notice |
| S121 | 2012-08-17 | 30-day Notice |
| S120 | 2012-08-03 | 30-day Notice |
| S119 | 2012-07-12 | Normal 180 Day Track |
| S118 | ||
| S117 | 2012-04-04 | Real-time Process |
| S116 | 2012-03-26 | Real-time Process |
| S115 | 2012-03-08 | Real-time Process |
| S114 | 2012-03-05 | 30-day Notice |
| S113 | 2012-02-27 | Real-time Process |
| S112 | 2012-02-24 | Real-time Process |
| S111 | 2012-02-15 | Special (immediate Track) |
| S110 | 2012-02-09 | Real-time Process |
| S109 | 2012-02-08 | 30-day Notice |
| S108 | 2012-01-24 | 135 Review Track For 30-day Notice |
| S107 | 2011-12-12 | Real-time Process |
| S106 | 2011-12-12 | 30-day Notice |
| S105 | 2011-11-22 | 135 Review Track For 30-day Notice |
| S104 | 2011-11-21 | Normal 180 Day Track |
| S103 | 2011-11-14 | 135 Review Track For 30-day Notice |
| S102 | 2011-11-07 | Normal 180 Day Track No User Fee |
| S101 | 2011-11-01 | Real-time Process |
| S100 | 2011-10-28 | Real-time Process |
| S099 | 2011-10-21 | Real-time Process |
| S098 | 2011-08-26 | 30-day Notice |
| S097 | 2011-04-22 | 30-day Notice |
| S096 | ||
| S095 | 2011-03-02 | 30-day Notice |
| S094 | ||
| S093 | 2011-02-17 | Real-time Process |
| S092 | 2010-12-15 | Real-time Process |
| S091 | 2010-12-14 | 30-day Notice |
| S090 | 2010-11-08 | Real-time Process |
| S089 | 2010-10-04 | Normal 180 Day Track No User Fee |
| S088 | 2010-10-04 | 30-day Notice |
| S087 | 2010-09-21 | 135 Review Track For 30-day Notice |
| S086 | 2010-09-17 | Real-time Process |
| S085 | 2010-09-13 | 30-day Notice |
| S084 | ||
| S083 | 2010-08-20 | Real-time Process |
| S082 | 2010-08-20 | 30-day Notice |
| S081 | 2010-08-10 | Real-time Process |
| S080 | 2010-06-28 | Real-time Process |
| S079 | 2010-06-17 | 30-day Notice |
| S078 | 2010-06-16 | 30-day Notice |
| S077 | 2010-06-10 | Real-time Process |
| S076 | 2010-06-07 | 135 Review Track For 30-day Notice |
| S075 | 2010-05-25 | Normal 180 Day Track |
| S074 | ||
| S073 | 2010-05-10 | Real-time Process |
| S072 | 2010-04-29 | 30-day Notice |
| S071 | 2010-04-22 | Normal 180 Day Track |
| S070 | 2010-03-05 | 30-day Notice |
| S069 | 2010-02-16 | Real-time Process |
| S068 | 2010-02-11 | Real-time Process |
| S067 | 2010-01-04 | Normal 180 Day Track |
| S066 | ||
| S065 | 2009-11-02 | 30-day Notice |
| S064 | 2009-10-09 | 30-day Notice |
| S063 | ||
| S062 | 2009-09-30 | 30-day Notice |
| S061 | 2009-09-29 | Real-time Process |
| S060 | 2009-09-28 | 30-day Notice |
| S059 | 2009-09-02 | 30-day Notice |
| S058 | 2009-07-29 | 30-day Notice |
| S057 | 2009-07-15 | 30-day Notice |
| S056 | 2009-06-23 | 30-day Notice |
| S055 | 2009-05-19 | 30-day Notice |
| S054 | 2009-05-06 | 30-day Notice |
| S053 | ||
| S052 | 2009-03-25 | Real-time Process |
| S051 | 2009-03-10 | 30-day Notice |
| S050 | 2009-03-10 | 30-day Notice |
| S049 | 2009-03-06 | 30-day Notice |
| S048 | 2009-02-27 | Real-time Process |
| S047 | 2009-02-09 | Real-time Process |
| S046 | 2009-02-02 | Normal 180 Day Track |
| S045 | ||
| S044 | ||
| S043 | 2008-12-04 | Real-time Process |
| S042 | 2008-11-26 | 30-day Notice |
| S041 | 2008-11-24 | Real-time Process |
| S040 | 2008-11-04 | 30-day Notice |
| S039 | 2008-10-30 | 30-day Notice |
| S038 | 2008-10-22 | 30-day Notice |
| S037 | 2008-10-21 | Normal 180 Day Track |
| S036 | 2008-09-26 | 30-day Notice |
| S035 | 2008-09-17 | 30-day Notice |
| S034 | 2008-08-29 | Normal 180 Day Track |
| S033 | 2008-08-18 | Real-time Process |
| S032 | 2008-08-12 | 30-day Notice |
| S031 | 2008-08-06 | Normal 180 Day Track |
| S030 | 2008-07-03 | 30-day Notice |
| S029 | 2008-06-18 | 30-day Notice |
| S028 | 2008-05-19 | Real-time Process |
| S027 | 2008-05-16 | 30-day Notice |
| S026 | 2008-03-06 | Real-time Process |
| S025 | 2008-01-28 | 30-day Notice |
| S024 | 2007-12-17 | Real-time Process |
| S023 | 2007-12-14 | Normal 180 Day Track |
| S022 | 2007-12-12 | 30-day Notice |
| S021 | 2007-10-24 | Normal 180 Day Track |
| S020 | 2007-06-19 | Normal 180 Day Track |
| S019 | 2007-03-09 | Normal 180 Day Track No User Fee |
| S018 | 2006-11-24 | Real-time Process |
| S017 | 2006-04-10 | Real-time Process |
| S016 | 2006-03-02 | Normal 180 Day Track No User Fee |
| S015 | 2006-02-27 | Panel Track |
| S014 | 2005-12-27 | Normal 180 Day Track No User Fee |
| S013 | 2005-10-04 | Normal 180 Day Track |
| S012 | 2005-02-28 | Normal 180 Day Track |
| S011 | 2004-08-20 | Panel Track |
| S010 | 2002-11-29 | Panel Track |
| S009 | 2002-06-06 | Normal 180 Day Track |
| S008 | 2002-04-15 | Normal 180 Day Track |
| S007 | 2001-06-05 | Normal 180 Day Track |
| S006 | 2000-09-21 | Normal 180 Day Track |
| S005 | ||
| S004 | ||
| S003 | 2000-02-14 | Real-time Process |
| S002 | ||
| S001 | 1999-09-15 | Normal 180 Day Track |