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 | Y ADAPTOR/EXTENDER KIT, DF-1 CONNECTOR POT PIN PLUG, HV SPLITTER/ADAPTOR KIT, IS-I CONNECTOR PORT PIN PLUG KIT, |
| Classification Name | Implantable Cardioverter Defibrillator (non-crt) |
| Generic Name | Implantable Cardioverter Defibrillator (non-crt) |
| Applicant | MEDTRONIC Inc. |
| Date Received | 2013-05-17 |
| Decision Date | 2013-07-23 |
| PMA | P920015 |
| Supplement | S113 |
| Product Code | LWS |
| 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 Ne ms Mv S11 mounds View, MN 55112 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P920015 | Original Filing | |
| S274 | 2023-01-09 | 30-day Notice |
| S273 | 2022-11-16 | 30-day Notice |
| S272 | 2022-10-19 | 30-day Notice |
| S271 | 2022-09-13 | 30-day Notice |
| S270 | 2022-06-17 | Normal 180 Day Track No User Fee |
| S269 | 2022-05-20 | 30-day Notice |
| S268 | 2022-04-27 | 30-day Notice |
| S267 | 2022-04-14 | 30-day Notice |
| S266 | 2022-02-23 | 30-day Notice |
| S265 | 2022-02-10 | 30-day Notice |
| S264 | 2022-01-13 | 30-day Notice |
| S263 | 2021-11-24 | 30-day Notice |
| S262 | 2021-11-19 | 30-day Notice |
| S261 | 2021-11-18 | 30-day Notice |
| S260 | 2021-11-03 | 30-day Notice |
| S259 | 2021-08-09 | 30-day Notice |
| S258 | 2021-08-04 | 30-day Notice |
| S257 | 2021-07-29 | 30-day Notice |
| S256 | ||
| S255 | 2021-06-15 | 30-day Notice |
| S254 | 2021-03-19 | 30-day Notice |
| S253 | 2021-02-05 | 30-day Notice |
| S252 | 2020-12-07 | Real-time Process |
| S251 | 2020-12-07 | 30-day Notice |
| S250 | 2020-12-01 | 30-day Notice |
| S249 | ||
| S248 | 2020-11-18 | 30-day Notice |
| S247 | 2020-10-23 | 30-day Notice |
| S246 | 2020-09-17 | 30-day Notice |
| S245 | 2020-07-09 | 30-day Notice |
| S244 | 2020-06-26 | 30-day Notice |
| S243 | 2020-03-23 | Real-time Process |
| S242 | 2020-02-20 | 30-day Notice |
| S241 | 2020-01-27 | 30-day Notice |
| S240 | 2019-12-17 | 30-day Notice |
| S239 | 2019-11-18 | 30-day Notice |
| S238 | 2019-11-13 | 30-day Notice |
| S237 | 2019-11-12 | 30-day Notice |
| S236 | 2019-09-16 | 30-day Notice |
| S235 | 2019-07-01 | 30-day Notice |
| S234 | ||
| S233 | 2019-06-20 | 30-day Notice |
| S232 | 2019-06-10 | 30-day Notice |
| S231 | 2019-05-31 | 30-day Notice |
| S230 | 2019-05-20 | 30-day Notice |
| S229 | 2019-05-02 | Normal 180 Day Track No User Fee |
| S228 | 2019-04-05 | 30-day Notice |
| S227 | 2019-03-04 | 30-day Notice |
| S226 | 2019-02-28 | 30-day Notice |
| S225 | 2019-01-30 | Normal 180 Day Track No User Fee |
| S224 | 2018-11-21 | 30-day Notice |
| S223 | 2018-11-02 | 30-day Notice |
| S222 | ||
| S221 | 2018-10-23 | 30-day Notice |
| S220 | 2018-10-18 | 30-day Notice |
| S219 | 2018-10-11 | 30-day Notice |
| S218 | 2018-09-26 | 30-day Notice |
| S217 | 2018-06-25 | Real-time Process |
| S216 | 2018-06-20 | 30-day Notice |
| S215 | 2018-06-01 | 30-day Notice |
| S214 | 2018-05-15 | 30-day Notice |
| S213 | 2018-04-13 | Normal 180 Day Track |
| S212 | 2018-04-09 | 30-day Notice |
| S211 | 2018-04-06 | 30-day Notice |
| S210 | 2018-03-28 | 30-day Notice |
| S209 | 2018-02-26 | 30-day Notice |
| S208 | 2018-02-22 | 30-day Notice |
| S207 | 2018-02-22 | 30-day Notice |
| S206 | 2018-02-12 | Real-time Process |
| S205 | 2017-12-21 | 30-day Notice |
| S204 | 2017-12-04 | Real-time Process |
| S203 | 2017-11-20 | 30-day Notice |
| S202 | 2017-08-09 | 30-day Notice |
| S201 | 2017-08-07 | 30-day Notice |
| S200 | 2017-06-28 | 30-day Notice |
| S199 | 2017-06-23 | 30-day Notice |
| S198 | 2017-06-07 | 30-day Notice |
| S197 | 2017-05-12 | 30-day Notice |
| S196 | 2017-01-25 | Real-time Process |
| S195 | 2017-01-17 | 30-day Notice |
| S194 | 2017-01-06 | 30-day Notice |
| S193 | 2016-12-23 | 30-day Notice |
| S192 | 2016-12-22 | 30-day Notice |
| S191 | 2016-12-06 | Normal 180 Day Track |
| S190 | 2016-11-28 | 30-day Notice |
| S189 | 2016-11-14 | 30-day Notice |
| S188 | 2016-11-02 | Normal 180 Day Track |
| S187 | 2016-10-25 | 30-day Notice |
| S186 | 2016-10-05 | 30-day Notice |
| S185 | 2016-09-22 | 30-day Notice |
| S184 | 2016-09-12 | 30-day Notice |
| S183 | 2016-09-02 | 30-day Notice |
| S182 | 2016-08-25 | 30-day Notice |
| S181 | 2016-06-24 | 30-day Notice |
| S180 | 2016-05-27 | 30-day Notice |
| S179 | 2016-05-03 | Normal 180 Day Track |
| S178 | 2016-04-15 | Normal 180 Day Track |
| S177 | 2016-03-11 | Normal 180 Day Track |
| S176 | 2016-03-08 | 30-day Notice |
| S175 | 2016-03-01 | Normal 180 Day Track |
| S174 | 2016-02-17 | 30-day Notice |
| S173 | 2016-01-14 | 30-day Notice |
| S172 | 2016-01-11 | 30-day Notice |
| S171 | 2016-01-07 | 30-day Notice |
| S170 | 2015-12-28 | 30-day Notice |
| S169 | 2015-12-22 | 30-day Notice |
| S168 | 2015-10-30 | Real-time Process |
| S167 | 2015-10-23 | 30-day Notice |
| S166 | 2015-10-13 | Normal 180 Day Track |
| S165 | 2015-09-30 | 30-day Notice |
| S164 | 2015-09-30 | Normal 180 Day Track |
| S163 | 2015-09-24 | Normal 180 Day Track |
| S162 | 2015-09-10 | 30-day Notice |
| S161 | 2015-07-14 | 30-day Notice |
| S160 | 2015-07-06 | 30-day Notice |
| S159 | 2015-07-02 | Real-time Process |
| S158 | 2015-06-25 | 30-day Notice |
| S157 | 2015-06-18 | 30-day Notice |
| S156 | 2015-06-08 | 30-day Notice |
| S155 | 2015-05-28 | Normal 180 Day Track |
| S154 | ||
| S153 | 2015-04-17 | 30-day Notice |
| S152 | 2015-04-14 | Real-time Process |
| S151 | 2015-03-16 | Normal 180 Day Track |
| S150 | 2015-03-12 | 30-day Notice |
| S149 | 2015-02-09 | 30-day Notice |
| S148 | 2015-02-09 | 30-day Notice |
| S147 | 2015-01-21 | 30-day Notice |
| S146 | 2014-12-22 | Normal 180 Day Track |
| S145 | 2014-10-15 | 30-day Notice |
| S144 | 2014-09-29 | 30-day Notice |
| S143 | 2014-09-15 | 30-day Notice |
| S142 | 2014-09-15 | 30-day Notice |
| S141 | 2014-09-05 | 30-day Notice |
| S140 | 2014-08-27 | 30-day Notice |
| S139 | 2014-08-13 | 30-day Notice |
| S138 | 2014-08-08 | 30-day Notice |
| S137 | 2014-07-28 | 30-day Notice |
| S136 | 2014-07-24 | 30-day Notice |
| S135 | 2014-07-14 | 30-day Notice |
| S134 | 2014-07-09 | 30-day Notice |
| S133 | 2014-07-02 | Real-time Process |
| S132 | 2014-06-16 | 30-day Notice |
| S131 | 2014-02-27 | 30-day Notice |
| S130 | ||
| S129 | 2014-01-29 | 30-day Notice |
| S128 | 2013-12-24 | 30-day Notice |
| S127 | 2013-12-19 | 30-day Notice |
| S126 | 2013-12-17 | 30-day Notice |
| S125 | 2013-11-27 | 30-day Notice |
| S124 | 2013-11-22 | 30-day Notice |
| S123 | 2013-10-30 | 30-day Notice |
| S122 | 2013-10-24 | Real-time Process |
| S121 | 2013-10-24 | 30-day Notice |
| S120 | 2013-09-30 | 30-day Notice |
| S119 | 2013-09-30 | 30-day Notice |
| S118 | 2013-09-17 | 30-day Notice |
| S117 | 2013-09-13 | Normal 180 Day Track No User Fee |
| S116 | 2013-09-13 | 30-day Notice |
| S115 | ||
| S114 | 2013-07-26 | 30-day Notice |
| S113 | 2013-05-17 | Real-time Process |
| S112 | ||
| S111 | 2013-04-30 | 30-day Notice |
| S110 | ||
| S109 | 2013-04-10 | Normal 180 Day Track No User Fee |
| S108 | 2013-04-08 | 135 Review Track For 30-day Notice |
| S107 | 2013-03-22 | 30-day Notice |
| S106 | 2013-03-21 | 30-day Notice |
| S105 | 2013-03-20 | 30-day Notice |
| S104 | 2012-12-21 | 30-day Notice |
| S103 | 2012-12-18 | 30-day Notice |
| S102 | 2012-12-10 | 30-day Notice |
| S101 | 2012-11-29 | 30-day Notice |
| S100 | 2012-11-21 | 30-day Notice |
| S099 | 2012-10-31 | Real-time Process |
| S098 | 2012-10-26 | Real-time Process |
| S097 | 2012-09-28 | 30-day Notice |
| S096 | 2012-09-21 | 30-day Notice |
| S095 | 2012-09-04 | 30-day Notice |
| S094 | 2012-08-03 | 30-day Notice |
| S093 | 2012-07-02 | Normal 180 Day Track |
| S092 | 2012-06-11 | 30-day Notice |
| S091 | 2012-05-23 | Real-time Process |
| S090 | 2012-03-26 | Real-time Process |
| S089 | 2012-03-07 | 30-day Notice |
| S088 | 2012-02-29 | 30-day Notice |
| S087 | 2012-02-27 | 30-day Notice |
| S086 | 2012-02-23 | 30-day Notice |
| S085 | 2011-11-25 | 30-day Notice |
| S084 | 2011-11-21 | Normal 180 Day Track |
| S083 | 2011-10-24 | 135 Review Track For 30-day Notice |
| S082 | 2011-07-18 | 30-day Notice |
| S081 | 2011-07-08 | 30-day Notice |
| S080 | 2011-06-28 | 30-day Notice |
| S079 | 2011-06-08 | 30-day Notice |
| S078 | 2011-06-08 | 135 Review Track For 30-day Notice |
| S077 | 2011-05-13 | 30-day Notice |
| S076 | 2011-04-26 | 30-day Notice |
| S075 | 2011-04-12 | 30-day Notice |
| S074 | 2011-03-22 | 135 Review Track For 30-day Notice |
| S073 | 2011-02-28 | 30-day Notice |
| S072 | 2010-12-10 | 30-day Notice |
| S071 | 2010-11-12 | 30-day Notice |
| S070 | 2010-10-26 | 30-day Notice |
| S069 | 2010-10-22 | Special (immediate Track) |
| S068 | 2010-10-14 | 30-day Notice |
| S067 | 2010-09-29 | 30-day Notice |
| S066 | ||
| S065 | 2010-07-15 | 30-day Notice |
| S064 | 2010-07-15 | 30-day Notice |
| S063 | 2010-07-15 | 30-day Notice |
| S062 | 2010-07-06 | 30-day Notice |
| S061 | 2010-06-28 | 135 Review Track For 30-day Notice |
| S060 | ||
| S059 | 2010-03-29 | 30-day Notice |
| S058 | 2010-01-19 | 30-day Notice |
| S057 | 2010-01-15 | Real-time Process |
| S056 | 2009-12-16 | Normal 180 Day Track No User Fee |
| S055 | 2009-12-04 | Normal 180 Day Track |
| S054 | 2009-03-26 | Normal 180 Day Track No User Fee |
| S053 | 2009-03-17 | Real-time Process |
| S052 | 2009-02-05 | 30-day Notice |
| S051 | 2008-12-11 | 30-day Notice |
| S050 | 2008-11-03 | 30-day Notice |
| S049 | 2008-10-27 | 30-day Notice |
| S048 | ||
| S047 | 2008-07-09 | 30-day Notice |
| S046 | 2008-06-17 | 30-day Notice |
| S045 | 2008-06-13 | 135 Review Track For 30-day Notice |
| S044 | 2008-04-14 | 30-day Notice |
| S043 | 2008-04-01 | 30-day Notice |
| S042 | 2008-03-31 | 30-day Notice |
| S041 | 2008-03-24 | 30-day Notice |
| S040 | 2008-03-10 | 135 Review Track For 30-day Notice |
| S039 | 2008-03-03 | Real-time Process |
| S038 | 2007-09-12 | 135 Review Track For 30-day Notice |
| S037 | 2007-05-15 | Real-time Process |
| S036 | 2006-11-20 | 30-day Notice |
| S035 | 2006-05-10 | 135 Review Track For 30-day Notice |
| S034 | ||
| S033 | ||
| S032 | 2005-09-02 | 135 Review Track For 30-day Notice |
| S031 | 2004-09-10 | Normal 180 Day Track |
| S030 | 2003-12-22 | Normal 180 Day Track |
| S029 | 2003-11-06 | Normal 180 Day Track |
| S028 | 2003-04-28 | Real-time Process |
| S027 | 2003-03-04 | 30-day Notice |
| S026 | ||
| S025 | 2001-11-05 | Special (immediate Track) |
| S024 | 2001-10-01 | Real-time Process |
| S023 | 2001-07-17 | 30-day Notice |
| S022 | 2001-05-31 | Real-time Process |
| S021 | 2001-02-05 | Normal 180 Day Track |
| S020 | 2000-11-13 | Real-time Process |
| S019 | ||
| S018 | ||
| S017 | 2000-06-20 | Normal 180 Day Track |
| S016 | 1999-08-12 | Special (immediate Track) |
| S015 | 1998-09-28 | Normal 180 Day Track |
| S014 | 1998-04-20 | |
| S013 | 1997-07-21 | Normal 180 Day Track |
| S012 | 1997-03-18 | Normal 180 Day Track |
| S011 | 1996-05-20 | Normal 180 Day Track |
| S010 | 1996-05-17 | Normal 180 Day Track |
| S009 | 1996-02-05 | Normal 180 Day Track |
| S008 | 1995-08-10 | Normal 180 Day Track |
| S007 | 1995-08-07 | Normal 180 Day Track |
| S006 | 1995-07-18 | Normal 180 Day Track |
| S005 | 1995-06-29 | Normal 180 Day Track |
| S004 | 1995-01-20 | Normal 180 Day Track |
| S003 | 1994-04-25 | Normal 180 Day Track |
| S002 | 1994-03-25 | Normal 180 Day Track |
| S001 | 1994-03-03 | Normal 180 Day Track |