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 modifications to the monitor and transmitter of the previously approved guardian rt system. The real-time monitor has a larger lcd for ease of viewing for the user and to support graphical display of the data. Also, in the real-time monitor, rf communication is received from the transmitter at 916. 35 mhz, which is the identical frequency used in the paradigm model mmt-515/715 insulin pumps (cleared under k040676). In addition, the meter readings for calibration can be manually entered, identical to the guardian rt, or automatically, via telemetry, when using the paradigm link meter in the identical scheme as in the previously cleared insulin pump. The calibration algorithm and glucose values reported by the system are identical between the guardian rt system and the guardian real-time system. The device, as modified, will be marketed under the trade name guardian real-time continuous glucose monitoring system and is indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adults (ages 18 and older) 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 finger stick may be required. All therapy adjustments should be based on measurements obtained using a home glucose meter and not on guardian real-time cgm system values. The guardian real-time cgm 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 values.
| Device | GUARDIAN REAL-TIME CONTINUOUS GLUCOSE MONITORING SYSTEM |
| Classification Name | Sensor, Glucose, Invasive |
| Generic Name | Sensor, Glucose, Invasive |
| Applicant | MEDTRONIC MINIMED |
| Date Received | 2006-04-10 |
| Decision Date | 2006-06-14 |
| PMA | P980022 |
| Supplement | S017 |
| Product Code | MDS |
| Advisory Committee | Clinical Chemistry |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDTRONIC MINIMED 18000 Devonshire St northridge, CA 91325 |
| 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 |