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 adding duplicate existing manufacturing steps to the preparation of bulk glucose oxidase (gox) performed by the supplier for use in the sponsor¿s enlite sensor (model: mmt-7008) and sof-sensor (models: mmt-7002 and mmt-7003) devices. The enlite sensor is a component of the minimed 530g system. The sof-sensor is a component of the paradigm real-time, paradigm realtime revel, guardian real-time, minilink real-time, ipro recorder and ipro2 professional continuous glucose monitoring systems.
| Device | SOF SENSOR |
| Classification Name | Sensor, Glucose, Invasive |
| Generic Name | Sensor, Glucose, Invasive |
| Applicant | MEDTRONIC MINIMED |
| Date Received | 2013-11-06 |
| Decision Date | 2015-10-02 |
| PMA | P980022 |
| Supplement | S140 |
| Product Code | MDS |
| Advisory Committee | Clinical Chemistry |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |