PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP

FDA Premarket Approval P980022 S146

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.

Pre-market Approval Supplement Details

Approval for changes in the welding process of the clear plastic window to the pump case of the paradigm real-time insulin pump (models: mmt-522, mmt-522k), the paradigm real-time revel insulin pump (models: mmt-523, mmt-523k) and the minimed 530g insulin pump (model: mmt-551). The paradigm real-time insulin pump is a part of the paradigm real-time system; the paradigm real-time revel insulin pump is a part of the paradigm real-time revel system; and the minimed 530g insulin pump is a part of the minimed 530g system.

DevicePARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP
Generic NameSensor, Glucose, Invasive
ApplicantMEDTRONIC MINIMED
Date Received2013-11-08
Decision Date2015-11-23
PMAP980022
SupplementS146
Advisory CommitteeClinical Chemistry
Supplement Type135 Review Track For 30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address MEDTRONIC MINIMED 18000 Devonshire St northridge, CA 91325

Supplemental Filings

Supplement NumberDateSupplement Type
P980022Original 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

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