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 percepta/percepta quad, serena/serena quad and solara/solara quad crt-p mri surescan implantable pulse generators with cardiac resynchronization therapy.
| Device | CAPSURE SENSE MRI SURESCAN LEAD |
| Classification Name | Drug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes |
| Generic Name | Drug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes |
| Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
| Date Received | 2016-12-06 |
| Decision Date | 2017-05-06 |
| PMA | P830061 |
| Supplement | S141 |
| Product Code | NVN |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 Coral Sea Street N.e. mounds View, MN 55112 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P830061 | Original Filing | |
| S211 | 2023-01-09 | 30-day Notice |
| S210 | 2022-11-16 | 30-day Notice |
| S209 | 2022-10-19 | 30-day Notice |
| S208 | 2022-09-13 | 30-day Notice |
| S207 | 2022-05-20 | 30-day Notice |
| S206 | 2022-04-14 | 30-day Notice |
| S205 | 2022-03-21 | 30-day Notice |
| S204 | 2022-02-23 | 30-day Notice |
| S203 | ||
| S202 | 2022-01-13 | 30-day Notice |
| S201 | 2021-11-19 | 30-day Notice |
| S200 | ||
| S199 | 2021-11-03 | 30-day Notice |
| S198 | 2021-08-13 | 30-day Notice |
| S197 | 2021-08-09 | 30-day Notice |
| S196 | 2021-07-06 | 30-day Notice |
| S195 | 2021-06-15 | 30-day Notice |
| S194 | 2021-03-19 | 30-day Notice |
| S193 | 2021-02-05 | 30-day Notice |
| S192 | 2021-01-12 | 30-day Notice |
| S191 | 2020-12-08 | 30-day Notice |
| S190 | 2020-12-07 | 30-day Notice |
| S189 | ||
| S188 | 2020-12-01 | 30-day Notice |
| S187 | 2020-11-24 | 30-day Notice |
| S186 | 2020-10-23 | 30-day Notice |
| S185 | 2020-09-17 | 30-day Notice |
| S184 | 2020-07-09 | 30-day Notice |
| S183 | 2020-07-08 | 30-day Notice |
| S182 | ||
| S181 | 2020-03-23 | Real-time Process |
| S180 | 2020-03-09 | 30-day Notice |
| S179 | 2020-02-20 | 30-day Notice |
| S178 | 2019-11-18 | 30-day Notice |
| S177 | 2019-11-18 | 30-day Notice |
| S176 | ||
| S175 | 2019-09-16 | 30-day Notice |
| S174 | 2019-07-01 | 30-day Notice |
| S173 | ||
| S172 | 2019-06-20 | 30-day Notice |
| S171 | 2019-06-18 | 30-day Notice |
| S170 | 2019-06-10 | 30-day Notice |
| S169 | 2019-05-29 | 30-day Notice |
| S168 | 2019-05-02 | Normal 180 Day Track No User Fee |
| S167 | 2019-02-28 | 30-day Notice |
| S166 | 2018-11-21 | 30-day Notice |
| S165 | ||
| S164 | 2018-10-23 | 30-day Notice |
| S163 | 2018-10-18 | 30-day Notice |
| S162 | 2018-09-26 | 30-day Notice |
| S161 | 2018-06-20 | 30-day Notice |
| S160 | 2018-06-01 | 30-day Notice |
| S159 | 2018-05-15 | 30-day Notice |
| S158 | 2018-05-11 | 30-day Notice |
| S157 | 2018-04-13 | Normal 180 Day Track |
| S156 | 2018-04-09 | 30-day Notice |
| S155 | 2018-03-28 | 30-day Notice |
| S154 | 2018-02-22 | 30-day Notice |
| S153 | 2017-12-04 | Real-time Process |
| S152 | 2017-11-20 | 30-day Notice |
| S151 | 2017-10-20 | 30-day Notice |
| S150 | 2017-10-13 | 30-day Notice |
| S149 | 2017-08-07 | 30-day Notice |
| S148 | 2017-06-28 | 30-day Notice |
| S147 | 2017-06-23 | 30-day Notice |
| S146 | 2017-06-07 | 30-day Notice |
| S145 | 2017-05-18 | Normal 180 Day Track |
| S144 | 2017-04-03 | Normal 180 Day Track |
| S143 | 2017-01-25 | Real-time Process |
| S142 | 2017-01-17 | 30-day Notice |
| S141 | 2016-12-06 | Normal 180 Day Track |
| S140 | 2016-12-06 | Normal 180 Day Track |
| S139 | 2016-11-28 | 30-day Notice |
| S138 | 2016-11-14 | 30-day Notice |
| S137 | 2016-11-02 | Normal 180 Day Track |
| S136 | 2016-10-05 | 30-day Notice |
| S135 | 2016-09-12 | 30-day Notice |
| S134 | 2016-09-02 | 30-day Notice |
| S133 | 2016-08-29 | 30-day Notice |
| S132 | 2016-08-25 | 30-day Notice |
| S131 | 2016-06-24 | 30-day Notice |
| S130 | 2016-05-03 | Normal 180 Day Track |
| S129 | 2016-04-15 | Normal 180 Day Track |
| S128 | 2016-03-17 | 30-day Notice |
| S127 | 2016-03-11 | Normal 180 Day Track |
| S126 | 2015-12-28 | 30-day Notice |
| S125 | 2015-12-22 | 30-day Notice |
| S124 | 2015-12-04 | 30-day Notice |
| S123 | 2015-12-01 | 30-day Notice |
| S122 | 2015-09-10 | 30-day Notice |
| S121 | 2015-04-17 | 30-day Notice |
| S120 | 2015-04-16 | 30-day Notice |
| S119 | 2015-03-25 | 30-day Notice |
| S118 | 2015-02-09 | 30-day Notice |
| S117 | 2014-09-29 | 30-day Notice |
| S116 | 2014-09-26 | 30-day Notice |
| S115 | 2014-08-27 | 30-day Notice |
| S114 | 2014-08-12 | 30-day Notice |
| S113 | 2014-08-08 | 30-day Notice |
| S112 | 2014-07-24 | 30-day Notice |
| S111 | 2014-07-14 | 30-day Notice |
| S110 | 2014-07-11 | 30-day Notice |
| S109 | 2014-06-19 | 30-day Notice |
| S108 | 2014-02-27 | 30-day Notice |
| S107 | 2014-01-29 | 30-day Notice |
| S106 | 2014-01-22 | 30-day Notice |
| S105 | 2013-12-24 | 30-day Notice |
| S104 | 2013-12-19 | 30-day Notice |
| S103 | ||
| S102 | 2013-12-12 | 30-day Notice |
| S101 | 2013-11-27 | 30-day Notice |
| S100 | 2013-10-30 | 30-day Notice |
| S099 | 2013-10-24 | 30-day Notice |
| S098 | 2013-09-30 | 30-day Notice |
| S097 | 2013-09-17 | 30-day Notice |
| S096 | 2013-06-07 | 30-day Notice |
| S095 | ||
| S094 | 2013-05-21 | 30-day Notice |
| S093 | 2013-05-17 | Real-time Process |
| S092 | 2013-04-30 | 30-day Notice |
| S091 | 2013-04-25 | 30-day Notice |
| S090 | ||
| S089 | 2013-04-10 | Normal 180 Day Track No User Fee |
| S088 | 2013-03-22 | 30-day Notice |
| S087 | 2013-03-20 | 30-day Notice |
| S086 | 2013-03-13 | Normal 180 Day Track |
| S085 | 2013-01-14 | 30-day Notice |
| S084 | 2012-12-10 | 30-day Notice |
| S083 | 2012-11-29 | 30-day Notice |
| S082 | 2012-11-21 | 30-day Notice |
| S081 | 2012-10-22 | 30-day Notice |
| S080 | 2012-10-17 | 30-day Notice |
| S079 | 2012-09-28 | 30-day Notice |
| S078 | 2012-09-04 | 30-day Notice |
| S077 | 2012-08-03 | 30-day Notice |
| S076 | 2012-06-11 | 30-day Notice |
| S075 | 2012-02-29 | 30-day Notice |
| S074 | 2011-11-25 | 30-day Notice |
| S073 | 2011-11-21 | Normal 180 Day Track |
| S072 | 2011-10-24 | 135 Review Track For 30-day Notice |
| S071 | 2011-07-18 | 30-day Notice |
| S070 | 2011-07-08 | 30-day Notice |
| S069 | 2011-06-28 | 30-day Notice |
| S068 | 2011-06-27 | 30-day Notice |
| S067 | 2011-06-08 | 30-day Notice |
| S066 | 2011-06-08 | 135 Review Track For 30-day Notice |
| S065 | 2011-05-13 | 30-day Notice |
| S064 | 2011-05-05 | Normal 180 Day Track No User Fee |
| S063 | 2011-04-26 | 30-day Notice |
| S062 | 2011-03-22 | 135 Review Track For 30-day Notice |
| S061 | 2011-03-18 | 135 Review Track For 30-day Notice |
| S060 | 2011-02-28 | 30-day Notice |
| S059 | 2010-11-12 | 30-day Notice |
| S058 | 2010-10-26 | 30-day Notice |
| S057 | 2010-09-29 | 30-day Notice |
| S056 | ||
| S055 | 2010-07-15 | 30-day Notice |
| S054 | 2010-07-15 | 30-day Notice |
| S053 | 2010-07-15 | 30-day Notice |
| S052 | 2010-06-28 | 135 Review Track For 30-day Notice |
| S051 | 2010-04-19 | 30-day Notice |
| S050 | 2010-03-29 | 30-day Notice |
| S049 | 2010-01-19 | 30-day Notice |
| S048 | 2010-01-15 | Real-time Process |
| S047 | 2009-10-08 | Real-time Process |
| S046 | 2009-03-17 | Real-time Process |
| S045 | 2009-02-05 | 30-day Notice |
| S044 | 2008-12-11 | 30-day Notice |
| S043 | ||
| S042 | 2008-04-23 | 135 Review Track For 30-day Notice |
| S041 | 2008-03-24 | 30-day Notice |
| S040 | 2008-03-10 | 135 Review Track For 30-day Notice |
| S039 | 2007-05-18 | 30-day Notice |
| S038 | ||
| S037 | 2004-03-01 | 135 Review Track For 30-day Notice |
| S036 | 2003-03-04 | 30-day Notice |
| S035 | 2002-12-24 | Real-time Process |
| S034 | 2002-03-01 | Normal 180 Day Track |
| S033 | 2001-11-05 | Special (immediate Track) |
| S032 | 2001-07-17 | 30-day Notice |
| S031 | 2000-01-11 | 30-day Notice |
| S030 | 1999-05-24 | Real-time Process |
| S029 | 1998-09-01 | Normal 180 Day Track |
| S028 | 1998-04-20 | Normal 180 Day Track |
| S027 | 1998-03-02 | Normal 180 Day Track |
| S026 | 1996-05-02 | Normal 180 Day Track |
| S025 | 1995-01-30 | Normal 180 Day Track |
| S024 | 1994-09-08 | Normal 180 Day Track |
| S023 | 1994-02-14 | Normal 180 Day Track |
| S022 | 1993-09-29 | Normal 180 Day Track |
| S021 | 1992-12-24 | Normal 180 Day Track |
| S020 | ||
| S019 | 1992-06-15 | Normal 180 Day Track |
| S018 | ||
| S017 | 1992-01-27 | Special (immediate Track) |
| S016 | ||
| S015 | 1990-01-07 | Normal 180 Day Track |
| S014 | 1990-07-24 | Normal 180 Day Track |
| S013 | 1990-05-15 | Normal 180 Day Track |
| S012 | 1990-05-10 | Normal 180 Day Track |
| S011 | 1989-11-01 | Normal 180 Day Track |
| S010 | 1989-08-09 | Normal 180 Day Track |
| S009 | 1989-03-02 | Normal 180 Day Track |
| S008 | 1989-01-23 | Normal 180 Day Track |
| S007 | 1988-10-21 | Normal 180 Day Track |
| S006 | 1988-07-18 | Normal 180 Day Track |
| S005 | 1988-01-20 | Normal 180 Day Track |
| S004 | 1987-03-05 | Normal 180 Day Track |
| S003 | 1987-02-02 | Normal 180 Day Track |
| S002 | 1986-09-25 | Normal 180 Day Track |
| S001 | 1986-09-11 | Normal 180 Day Track |