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.
Updates to process parameters for the blister process and acceptance criteria for minimum blister sealed width.
| Device | CapSure Sense 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 | 2018-05-11 |
| Decision Date | 2018-05-31 |
| PMA | P830061 |
| Supplement | S158 |
| Product Code | NVN |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |