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 an increase in the storage shelf life of the tyvek lid component, which includes the adhesive coating, used in the medtronic cardiac rhythm disease management products from 18 months to 48 months.
| Device | CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, SUREFIX LEAD, TORQUE CLIP DEVICE-ACCESSORY FOR 5076 LEAD |
| Classification Name | Permanent Defibrillator Electrodes |
| Generic Name | Permanent Defibrillator Electrodes |
| Applicant | Medtronic, Inc. |
| Date Received | 2013-05-17 |
| Decision Date | 2013-07-23 |
| PMA | P930039 |
| Supplement | S089 |
| Product Code | NVY |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Medtronic, Inc. 8200 Coral Sea Street N.e. mounds View, MN 55112 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P930039 | Original Filing | |
| S248 | 2023-01-09 | 30-day Notice |
| S247 | 2022-11-16 | 30-day Notice |
| S246 | 2022-10-19 | 30-day Notice |
| S245 | 2022-09-13 | 30-day Notice |
| S244 | 2022-06-17 | Normal 180 Day Track No User Fee |
| S243 | 2022-05-20 | 30-day Notice |
| S242 | 2022-05-10 | 30-day Notice |
| S241 | 2022-04-14 | 30-day Notice |
| S240 | 2022-03-21 | 30-day Notice |
| S239 | 2022-02-23 | 30-day Notice |
| S238 | ||
| S237 | 2022-01-28 | 30-day Notice |
| S236 | 2022-01-13 | 30-day Notice |
| S235 | 2021-11-19 | 30-day Notice |
| S234 | ||
| S233 | ||
| S232 | 2021-09-24 | 30-day Notice |
| S231 | 2021-09-23 | 30-day Notice |
| S230 | 2021-08-20 | 30-day Notice |
| S229 | 2021-08-09 | 30-day Notice |
| S228 | 2021-06-15 | 30-day Notice |
| S227 | 2021-05-03 | 30-day Notice |
| S226 | 2021-04-28 | 30-day Notice |
| S225 | 2021-04-20 | 30-day Notice |
| S224 | 2021-03-19 | 30-day Notice |
| S223 | 2021-02-05 | 30-day Notice |
| S222 | 2020-12-08 | 30-day Notice |
| S221 | 2020-12-07 | 30-day Notice |
| S220 | ||
| S219 | 2020-12-01 | 30-day Notice |
| S218 | ||
| S217 | 2020-10-23 | 30-day Notice |
| S216 | 2020-10-15 | 30-day Notice |
| S215 | 2020-09-17 | 30-day Notice |
| S214 | 2020-07-09 | 30-day Notice |
| S213 | 2020-07-08 | 30-day Notice |
| S212 | ||
| S211 | 2020-03-23 | Real-time Process |
| S210 | 2020-02-20 | 30-day Notice |
| S209 | 2020-01-31 | 30-day Notice |
| S208 | 2019-11-18 | 30-day Notice |
| S207 | 2019-11-18 | 30-day Notice |
| S206 | ||
| S205 | 2019-11-12 | 30-day Notice |
| S204 | 2019-09-11 | 30-day Notice |
| S203 | 2019-07-01 | 30-day Notice |
| S202 | ||
| S201 | 2019-06-20 | 30-day Notice |
| S200 | 2019-06-18 | 30-day Notice |
| S199 | 2019-06-10 | 30-day Notice |
| S198 | 2019-05-29 | 30-day Notice |
| S197 | 2019-05-02 | Normal 180 Day Track No User Fee |
| S196 | 2019-02-28 | 30-day Notice |
| S195 | 2018-11-21 | 30-day Notice |
| S194 | ||
| S193 | 2018-10-23 | 30-day Notice |
| S192 | 2018-10-18 | 30-day Notice |
| S191 | 2018-09-26 | 30-day Notice |
| S190 | 2018-06-20 | 30-day Notice |
| S189 | 2018-06-01 | 30-day Notice |
| S188 | 2018-05-15 | 30-day Notice |
| S187 | 2018-05-11 | 30-day Notice |
| S186 | 2018-04-13 | Normal 180 Day Track |
| S185 | 2018-04-09 | 30-day Notice |
| S184 | 2018-04-06 | 30-day Notice |
| S183 | 2018-03-28 | 30-day Notice |
| S182 | 2018-03-16 | 30-day Notice |
| S181 | 2018-03-06 | 30-day Notice |
| S180 | 2018-02-22 | 30-day Notice |
| S179 | 2017-12-04 | Real-time Process |
| S178 | 2017-11-20 | 30-day Notice |
| S177 | 2017-10-20 | 30-day Notice |
| S176 | 2017-10-13 | 30-day Notice |
| S175 | 2017-08-07 | 30-day Notice |
| S174 | 2017-06-28 | 30-day Notice |
| S173 | 2017-06-23 | 30-day Notice |
| S172 | 2017-06-07 | 30-day Notice |
| S171 | 2017-06-02 | 30-day Notice |
| S170 | 2017-05-18 | Normal 180 Day Track |
| S169 | 2017-04-03 | Normal 180 Day Track |
| S168 | 2017-01-25 | Real-time Process |
| S167 | 2017-01-24 | 30-day Notice |
| S166 | 2016-12-06 | Normal 180 Day Track |
| S165 | 2016-12-06 | Normal 180 Day Track |
| S164 | 2016-11-28 | 30-day Notice |
| S163 | 2016-11-14 | 30-day Notice |
| S162 | 2016-11-02 | Normal 180 Day Track |
| S161 | 2016-10-05 | 30-day Notice |
| S160 | 2016-09-23 | 30-day Notice |
| S159 | 2016-09-12 | 30-day Notice |
| S158 | 2016-09-02 | 30-day Notice |
| S157 | 2016-08-29 | 30-day Notice |
| S156 | 2016-08-25 | 30-day Notice |
| S155 | 2016-08-02 | 30-day Notice |
| S154 | 2016-07-26 | 30-day Notice |
| S153 | 2016-06-24 | 30-day Notice |
| S152 | 2016-05-03 | Normal 180 Day Track |
| S151 | 2016-04-15 | Normal 180 Day Track |
| S150 | 2016-03-23 | 30-day Notice |
| S149 | 2016-03-11 | Normal 180 Day Track |
| S148 | 2016-03-01 | Normal 180 Day Track |
| S147 | 2015-12-28 | 30-day Notice |
| S146 | 2015-12-28 | 30-day Notice |
| S145 | 2015-12-22 | 30-day Notice |
| S144 | 2015-12-04 | 30-day Notice |
| S143 | 2015-10-23 | 30-day Notice |
| S142 | 2015-10-13 | Normal 180 Day Track |
| S141 | 2015-09-30 | 30-day Notice |
| S140 | 2015-09-24 | Normal 180 Day Track |
| S139 | 2015-09-17 | 30-day Notice |
| S138 | 2015-03-16 | Normal 180 Day Track |
| S137 | 2015-09-10 | 30-day Notice |
| S136 | 2015-07-20 | 30-day Notice |
| S135 | 2015-07-01 | 30-day Notice |
| S134 | 2015-06-19 | 30-day Notice |
| S133 | 2015-06-18 | 30-day Notice |
| S132 | 2015-05-18 | 30-day Notice |
| S131 | 2015-05-18 | 30-day Notice |
| S130 | 2015-04-20 | Normal 180 Day Track |
| S129 | 2015-04-17 | 30-day Notice |
| S128 | 2015-04-16 | 30-day Notice |
| S127 | 2015-03-26 | 30-day Notice |
| S126 | 2015-02-26 | 30-day Notice |
| S125 | 2015-02-09 | 30-day Notice |
| S124 | 2015-01-21 | 30-day Notice |
| S123 | 2014-12-08 | Normal 180 Day Track |
| S122 | 2014-12-08 | 30-day Notice |
| S121 | 2014-09-29 | 30-day Notice |
| S120 | 2014-09-26 | 30-day Notice |
| S119 | 2014-09-15 | 30-day Notice |
| S118 | 2014-08-27 | 30-day Notice |
| S117 | 2014-08-27 | 30-day Notice |
| S116 | 2014-08-12 | 30-day Notice |
| S115 | 2014-08-08 | 30-day Notice |
| S114 | 2014-07-28 | 30-day Notice |
| S113 | 2014-07-24 | 30-day Notice |
| S112 | 2014-07-11 | 30-day Notice |
| S111 | 2014-06-19 | 30-day Notice |
| S110 | 2014-06-16 | 30-day Notice |
| S109 | 2014-05-22 | 30-day Notice |
| S108 | 2014-05-12 | 30-day Notice |
| S107 | 2014-04-17 | Normal 180 Day Track |
| S106 | 2014-03-07 | 30-day Notice |
| S105 | 2014-02-27 | 30-day Notice |
| S104 | 2014-01-29 | 30-day Notice |
| S103 | 2014-01-22 | 30-day Notice |
| S102 | 2013-12-24 | 30-day Notice |
| S101 | 2013-12-19 | 30-day Notice |
| S100 | 2013-12-17 | 30-day Notice |
| S099 | ||
| S098 | 2013-12-12 | 30-day Notice |
| S097 | 2013-11-27 | 30-day Notice |
| S096 | 2013-10-30 | 30-day Notice |
| S095 | 2013-10-24 | 30-day Notice |
| S094 | 2013-09-30 | 30-day Notice |
| S093 | 2013-09-17 | 30-day Notice |
| S092 | 2013-06-07 | 30-day Notice |
| S091 | ||
| S090 | 2013-05-21 | 30-day Notice |
| S089 | 2013-05-17 | Real-time Process |
| S088 | 2013-04-30 | 30-day Notice |
| S087 | 2013-04-25 | 30-day Notice |
| S086 | ||
| S085 | 2013-04-09 | Normal 180 Day Track No User Fee |
| S084 | 2013-03-22 | 30-day Notice |
| S083 | 2013-03-20 | 30-day Notice |
| S082 | 2013-01-14 | 30-day Notice |
| S081 | 2012-12-17 | 30-day Notice |
| S080 | 2012-12-10 | 30-day Notice |
| S079 | 2012-11-29 | 30-day Notice |
| S078 | 2012-11-21 | 30-day Notice |
| S077 | 2012-11-01 | 30-day Notice |
| S076 | 2012-10-22 | 30-day Notice |
| S075 | 2012-09-28 | 30-day Notice |
| S074 | 2012-09-21 | 30-day Notice |
| S073 | 2012-09-04 | 30-day Notice |
| S072 | 2012-08-31 | Normal 180 Day Track No User Fee |
| S071 | 2012-08-03 | 30-day Notice |
| S070 | 2012-07-18 | 30-day Notice |
| S069 | 2012-07-13 | 30-day Notice |
| S068 | 2012-06-11 | 30-day Notice |
| S067 | 2012-03-09 | 30-day Notice |
| S066 | 2012-02-29 | 30-day Notice |
| S065 | 2011-11-25 | 30-day Notice |
| S064 | 2011-11-21 | Normal 180 Day Track |
| S063 | 2011-10-24 | 135 Review Track For 30-day Notice |
| S062 | 2011-08-12 | 30-day Notice |
| S061 | 2011-07-18 | 30-day Notice |
| S060 | 2011-07-08 | 30-day Notice |
| S059 | 2011-06-28 | 30-day Notice |
| S058 | 2011-06-27 | 30-day Notice |
| S057 | 2011-06-08 | 30-day Notice |
| S056 | 2011-06-08 | 135 Review Track For 30-day Notice |
| S055 | 2011-06-01 | 30-day Notice |
| S054 | ||
| S053 | 2011-05-13 | 30-day Notice |
| S052 | 2011-04-26 | 30-day Notice |
| S051 | 2011-04-22 | 30-day Notice |
| S050 | 2011-03-22 | 135 Review Track For 30-day Notice |
| S049 | 2011-03-18 | 135 Review Track For 30-day Notice |
| S048 | 2011-02-28 | 30-day Notice |
| S047 | 2010-11-12 | 30-day Notice |
| S046 | 2010-10-26 | 30-day Notice |
| S045 | 2010-09-29 | 30-day Notice |
| S044 | ||
| S043 | 2010-07-28 | 30-day Notice |
| S042 | 2010-07-15 | 30-day Notice |
| S041 | 2010-07-15 | 30-day Notice |
| S040 | 2010-07-15 | 30-day Notice |
| S039 | 2010-06-28 | 135 Review Track For 30-day Notice |
| S038 | ||
| S037 | 2010-04-19 | 30-day Notice |
| S036 | 2010-03-29 | 30-day Notice |
| S035 | 2010-01-19 | 30-day Notice |
| S034 | 2009-10-09 | 30-day Notice |
| S033 | 2009-10-08 | Real-time Process |
| S032 | 2009-04-10 | 30-day Notice |
| S031 | 2009-03-17 | Real-time Process |
| S030 | 2009-02-05 | 30-day Notice |
| S029 | 2008-12-11 | 30-day Notice |
| S028 | ||
| S027 | 2008-04-23 | 135 Review Track For 30-day Notice |
| S026 | 2008-03-24 | 30-day Notice |
| S025 | 2008-03-10 | 135 Review Track For 30-day Notice |
| S024 | 2008-01-04 | 30-day Notice |
| S023 | 2007-06-27 | 30-day Notice |
| S022 | 2007-05-18 | 30-day Notice |
| S021 | ||
| S020 | 2004-09-10 | Normal 180 Day Track |
| S019 | 2004-03-01 | 135 Review Track For 30-day Notice |
| S018 | 2004-02-10 | 30-day Notice |
| S017 | 2003-11-13 | Real-time Process |
| S016 | 2003-07-02 | Real-time Process |
| S015 | 2003-03-04 | 30-day Notice |
| S014 | 2002-12-24 | Real-time Process |
| S013 | 2001-11-14 | Real-time Process |
| S012 | 2001-11-05 | Special (immediate Track) |
| S011 | ||
| S010 | 2001-07-17 | 30-day Notice |
| S009 | 2000-03-13 | Normal 180 Day Track |
| S008 | 2000-01-11 | 30-day Notice |
| S007 | 2000-01-05 | 30-day Notice |
| S006 | 1998-04-20 | |
| S005 | 1998-03-02 | Normal 180 Day Track |
| S004 | 1997-11-17 | Normal 180 Day Track |
| S003 | 1996-11-21 | Normal 180 Day Track |
| S002 | 1996-06-24 | Normal 180 Day Track |
| S001 | 1996-05-02 | Normal 180 Day Track |