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.
Transfer of purchasing, receiving, and incoming inspection activities ofcertain external insulin pump components used in the manufacture of the paradigm real-timepump series and the minimed 530g series from the medtronic minimed northridge facility to the medtronic puerto rico operations company and fedex/3pl facilities in puerto rico. The paradigm real? ]time family of insulin pumps and the minimed 530g insulin pump are components of the paradigm real-time/real-time revel systems and the minimed 530g system, respectively.
| Device | PARADIGM REAL-TIME INSULIN PUMPS, PARADIGM REAL-TIME REVEL INSULIN PUMPS |
| Classification Name | Sensor, Glucose, Invasive |
| Generic Name | Sensor, Glucose, Invasive |
| Applicant | MEDTRONIC MINIMED |
| Date Received | 2015-03-18 |
| Decision Date | 2015-04-16 |
| PMA | P980022 |
| Supplement | S180 |
| Product Code | MDS |
| 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 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 |