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 pacing leads that incorporate a new surface coating, a new electrode geometry, a new combination of previously used steroids, and a new tapered stylet. The device, as modified, will be marketed under the trade names capsure sense lead models 4074/4574/4073 and the vitatron crystalline lead models icm09b, icm09jb, and icm09. These devices are indicated for pacing or sensing in the atrium or ventricle. The leads have application where implantable atrial or ventricular single-chamber or dual-chamber pacing systems are indicated.
| Device | CAPSURE SENSE LEAD MODELS |
| Classification Name | Permanent Pacemaker Electrode |
| Generic Name | Permanent Pacemaker Electrode |
| Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
| Date Received | 2002-03-01 |
| Decision Date | 2002-07-23 |
| PMA | P830061 |
| Supplement | S034 |
| Product Code | DTB |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| 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 |