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 extendable/retractable screw-in pacing lead. The device, as modified, will be marketed under the trade names medtronic capsure(r)fix novus model 5076 and vitatron crystalline(r) actfix model icf09 pacing leads. These devices are indicated for permanent pacing and sensing of the ventricle and/or atrium when used with a compatible pule generator.
| Device | CAPSUREFIX(R) |
| Classification Name | Permanent Pacemaker Electrode |
| Generic Name | Permanent Pacemaker Electrode |
| Applicant | Medtronic, Inc. |
| Date Received | 2000-03-13 |
| Decision Date | 2000-08-31 |
| PMA | P930039 |
| Supplement | S009 |
| 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, 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 |