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 software updates to the merlin@home v8. 2. 2 to increase the cybersecurity of the system.
| Device | Promote/+/RF/Q, PROMOTE ACCEL, PROMOTE QUADRA, UNIFY,UNIFY ASSURA, UNIFY QUADRA |
| Classification Name | Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d) |
| Generic Name | Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d) |
| Applicant | St. Jude Medical |
| Date Received | 2016-12-14 |
| Decision Date | 2017-01-31 |
| PMA | P030054 |
| Supplement | S316 |
| Product Code | NIK |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | St. Jude Medical 15900 Valley View Ct. sylmar, CA 91342-3577 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P030054 | Original Filing | |
| S402 | 2022-08-24 | 30-day Notice |
| S401 | ||
| S400 | 2022-07-14 | 30-day Notice |
| S399 | 2022-07-01 | 30-day Notice |
| S398 | 2022-03-07 | Real-time Process |
| S397 | 2021-10-18 | Real-time Process |
| S396 | 2021-10-18 | Real-time Process |
| S395 | 2021-08-04 | 30-day Notice |
| S394 | ||
| S393 | 2021-06-28 | 30-day Notice |
| S392 | 2021-04-02 | Real-time Process |
| S391 | 2021-03-12 | 30-day Notice |
| S390 | 2021-02-19 | 30-day Notice |
| S389 | ||
| S388 | 2020-11-25 | 30-day Notice |
| S387 | 2020-10-21 | 30-day Notice |
| S386 | 2020-10-21 | 30-day Notice |
| S385 | 2020-08-31 | 30-day Notice |
| S384 | ||
| S383 | 2020-07-17 | 30-day Notice |
| S382 | ||
| S381 | ||
| S380 | ||
| S379 | 2020-05-22 | 30-day Notice |
| S378 | 2020-04-24 | 30-day Notice |
| S377 | 2020-02-27 | 30-day Notice |
| S376 | 2020-02-13 | 30-day Notice |
| S375 | 2019-12-09 | 30-day Notice |
| S374 | ||
| S373 | 2019-10-30 | Real-time Process |
| S372 | 2019-10-09 | Normal 180 Day Track No User Fee |
| S371 | 2019-09-23 | 30-day Notice |
| S370 | 2019-08-07 | 30-day Notice |
| S369 | 2019-07-24 | 30-day Notice |
| S368 | ||
| S367 | 2018-11-30 | 30-day Notice |
| S366 | 2018-11-23 | 30-day Notice |
| S365 | 2018-11-20 | 30-day Notice |
| S364 | 2018-10-29 | Real-time Process |
| S363 | 2018-10-09 | 30-day Notice |
| S362 | 2018-10-02 | 30-day Notice |
| S361 | 2018-10-01 | 30-day Notice |
| S360 | 2018-09-28 | 30-day Notice |
| S359 | 2018-07-25 | Normal 180 Day Track No User Fee |
| S358 | 2018-07-17 | 30-day Notice |
| S357 | 2018-07-02 | 30-day Notice |
| S356 | 2018-06-28 | Normal 180 Day Track |
| S355 | 2018-06-20 | Normal 180 Day Track |
| S354 | 2018-05-21 | 30-day Notice |
| S353 | 2018-04-05 | 30-day Notice |
| S352 | 2018-03-14 | 30-day Notice |
| S351 | 2018-03-12 | 30-day Notice |
| S350 | 2018-03-05 | 30-day Notice |
| S349 | 2018-02-27 | 30-day Notice |
| S348 | 2018-01-31 | 30-day Notice |
| S347 | 2018-01-29 | 30-day Notice |
| S346 | 2018-01-26 | 30-day Notice |
| S345 | 2018-01-18 | 30-day Notice |
| S344 | 2018-01-18 | Normal 180 Day Track |
| S343 | 2017-12-21 | 30-day Notice |
| S342 | 2017-11-13 | 30-day Notice |
| S341 | 2017-11-13 | 30-day Notice |
| S340 | 2017-10-30 | Real-time Process |
| S339 | 2017-10-10 | 30-day Notice |
| S338 | 2017-09-22 | 30-day Notice |
| S337 | 2017-09-21 | 30-day Notice |
| S336 | 2017-08-16 | 30-day Notice |
| S335 | 2017-08-01 | 30-day Notice |
| S334 | 2017-07-31 | Real-time Process |
| S333 | 2017-07-31 | Real-time Process |
| S332 | 2017-07-03 | Normal 180 Day Track |
| S331 | 2017-06-29 | 30-day Notice |
| S330 | 2017-06-27 | 30-day Notice |
| S329 | 2017-05-17 | Normal 180 Day Track |
| S328 | 2017-04-06 | 30-day Notice |
| S327 | 2017-04-03 | Real-time Process |
| S326 | 2017-04-03 | Normal 180 Day Track |
| S325 | 2017-02-28 | 30-day Notice |
| S324 | 2017-02-24 | 30-day Notice |
| S323 | 2017-02-17 | 135 Review Track For 30-day Notice |
| S322 | 2017-02-10 | 30-day Notice |
| S321 | 2017-02-07 | Real-time Process |
| S320 | 2017-02-01 | Real-time Process |
| S319 | 2017-01-30 | 30-day Notice |
| S318 | 2017-01-26 | 30-day Notice |
| S317 | 2017-01-25 | 30-day Notice |
| S316 | 2016-12-14 | Real-time Process |
| S315 | 2016-12-13 | 30-day Notice |
| S314 | 2016-11-14 | Normal 180 Day Track |
| S313 | 2016-10-21 | 30-day Notice |
| S312 | 2016-10-12 | 30-day Notice |
| S311 | 2016-09-27 | 135 Review Track For 30-day Notice |
| S310 | 2016-09-13 | 135 Review Track For 30-day Notice |
| S309 | ||
| S308 | 2016-07-05 | 30-day Notice |
| S307 | 2016-07-05 | Real-time Process |
| S306 | 2016-06-24 | 30-day Notice |
| S305 | 2016-06-22 | 30-day Notice |
| S304 | 2016-04-26 | Real-time Process |
| S303 | 2016-04-12 | 30-day Notice |
| S302 | 2016-04-04 | Real-time Process |
| S301 | 2016-02-03 | Real-time Process |
| S300 | ||
| S299 | 2016-01-21 | 30-day Notice |
| S298 | 2016-01-19 | 30-day Notice |
| S297 | 2016-01-12 | 30-day Notice |
| S296 | 2015-11-25 | 30-day Notice |
| S295 | 2015-10-26 | 135 Review Track For 30-day Notice |
| S294 | 2015-09-29 | Real-time Process |
| S293 | 2015-09-17 | 30-day Notice |
| S292 | 2015-09-15 | Normal 180 Day Track |
| S291 | 2015-08-17 | Normal 180 Day Track |
| S290 | 2015-08-17 | Real-time Process |
| S289 | 2015-08-13 | 30-day Notice |
| S288 | 2015-08-10 | 30-day Notice |
| S287 | 2015-07-23 | Real-time Process |
| S286 | 2015-05-19 | Real-time Process |
| S285 | 2015-03-25 | 30-day Notice |
| S284 | 2015-02-11 | Normal 180 Day Track |
| S283 | 2015-02-04 | Real-time Process |
| S282 | 2015-01-28 | 30-day Notice |
| S281 | 2014-12-18 | Real-time Process |
| S280 | 2014-12-08 | Real-time Process |
| S279 | 2014-11-17 | 30-day Notice |
| S278 | 2014-11-03 | Real-time Process |
| S277 | 2014-10-27 | 30-day Notice |
| S276 | 2014-10-20 | Real-time Process |
| S275 | 2014-09-26 | 30-day Notice |
| S274 | 2014-08-22 | Real-time Process |
| S273 | 2014-07-02 | Normal 180 Day Track |
| S272 | 2014-06-30 | 30-day Notice |
| S271 | 2014-06-16 | 30-day Notice |
| S270 | 2014-05-30 | 30-day Notice |
| S269 | 2014-05-28 | 30-day Notice |
| S268 | 2014-05-22 | Real-time Process |
| S267 | 2014-04-30 | 30-day Notice |
| S266 | 2014-04-21 | 30-day Notice |
| S265 | 2014-04-15 | Real-time Process |
| S264 | ||
| S263 | 2014-02-18 | 30-day Notice |
| S262 | 2014-02-28 | Real-time Process |
| S261 | 2014-02-05 | 30-day Notice |
| S260 | 2014-02-05 | 30-day Notice |
| S259 | 2014-01-24 | Real-time Process |
| S258 | 2014-01-23 | 30-day Notice |
| S257 | ||
| S256 | 2014-01-13 | 30-day Notice |
| S255 | 2013-11-29 | 30-day Notice |
| S254 | 2013-11-21 | Normal 180 Day Track |
| S253 | 2013-10-28 | 30-day Notice |
| S252 | 2013-07-31 | 30-day Notice |
| S251 | 2013-05-13 | 30-day Notice |
| S250 | 2013-05-13 | 30-day Notice |
| S249 | ||
| S248 | 2013-05-13 | 30-day Notice |
| S247 | ||
| S246 | 2013-06-03 | Real-time Process |
| S245 | 2013-04-15 | 30-day Notice |
| S244 | 2013-03-14 | 30-day Notice |
| S243 | 2013-01-30 | 30-day Notice |
| S242 | 2012-12-11 | 135 Review Track For 30-day Notice |
| S241 | 2012-12-05 | Normal 180 Day Track |
| S240 | ||
| S239 | 2012-11-21 | 30-day Notice |
| S238 | 2012-11-14 | Normal 180 Day Track |
| S237 | 2012-10-15 | Normal 180 Day Track |
| S236 | 2012-10-15 | Normal 180 Day Track No User Fee |
| S235 | 2012-09-28 | 30-day Notice |
| S234 | ||
| S233 | 2012-09-13 | 30-day Notice |
| S232 | 2012-09-05 | Real-time Process |
| S231 | 2012-08-27 | 30-day Notice |
| S230 | 2012-08-16 | Real-time Process |
| S229 | ||
| S228 | 2012-08-07 | 30-day Notice |
| S227 | 2012-07-19 | Normal 180 Day Track No User Fee |
| S226 | 2012-07-11 | Normal 180 Day Track |
| S225 | 2012-07-10 | 30-day Notice |
| S224 | 2012-05-30 | Real-time Process |
| S223 | 2012-05-25 | Normal 180 Day Track |
| S222 | 2012-05-22 | 30-day Notice |
| S221 | 2012-04-03 | 30-day Notice |
| S220 | 2012-02-29 | Real-time Process |
| S219 | ||
| S218 | 2012-02-22 | Real-time Process |
| S217 | 2012-02-13 | 135 Review Track For 30-day Notice |
| S216 | 2012-02-13 | 30-day Notice |
| S215 | 2012-02-10 | 30-day Notice |
| S214 | 2012-01-04 | Normal 180 Day Track No User Fee |
| S213 | ||
| S212 | 2011-12-23 | Normal 180 Day Track No User Fee |
| S211 | ||
| S210 | ||
| S209 | 2011-12-05 | 30-day Notice |
| S208 | 2011-11-30 | 135 Review Track For 30-day Notice |
| S207 | 2011-11-04 | 30-day Notice |
| S206 | 2011-11-01 | Normal 180 Day Track |
| S205 | 2011-10-26 | 30-day Notice |
| S204 | 2011-10-25 | 30-day Notice |
| S203 | 2011-09-13 | 30-day Notice |
| S202 | 2011-09-12 | Real-time Process |
| S201 | 2011-09-09 | 30-day Notice |
| S200 | 2011-09-02 | Real-time Process |
| S199 | 2011-08-31 | Real-time Process |
| S198 | 2011-08-08 | Real-time Process |
| S197 | 2011-07-26 | Real-time Process |
| S196 | 2011-07-19 | Normal 180 Day Track |
| S195 | 2011-07-18 | 30-day Notice |
| S194 | 2011-07-15 | 30-day Notice |
| S193 | 2011-06-28 | Real-time Process |
| S192 | 2011-06-20 | Real-time Process |
| S191 | 2011-05-18 | Normal 180 Day Track No User Fee |
| S190 | 2011-05-11 | 135 Review Track For 30-day Notice |
| S189 | 2011-05-02 | Normal 180 Day Track |
| S188 | 2011-04-19 | Normal 180 Day Track |
| S187 | 2011-04-11 | 30-day Notice |
| S186 | 2011-04-05 | 30-day Notice |
| S185 | 2011-04-05 | 30-day Notice |
| S184 | ||
| S183 | 2011-03-22 | 135 Review Track For 30-day Notice |
| S182 | 2011-03-18 | Real-time Process |
| S181 | 2011-03-14 | Normal 180 Day Track |
| S180 | 2011-03-09 | 135 Review Track For 30-day Notice |
| S179 | 2010-12-09 | 30-day Notice |
| S178 | 2010-12-03 | 30-day Notice |
| S177 | 2010-11-23 | Normal 180 Day Track |
| S176 | 2010-11-22 | 135 Review Track For 30-day Notice |
| S175 | 2010-11-15 | 30-day Notice |
| S174 | 2010-11-12 | 30-day Notice |
| S173 | 2010-10-29 | Normal 180 Day Track |
| S172 | 2010-09-29 | 30-day Notice |
| S171 | 2010-09-20 | 30-day Notice |
| S170 | 2010-08-20 | Real-time Process |
| S169 | 2010-08-19 | Real-time Process |
| S168 | 2010-08-16 | Normal 180 Day Track No User Fee |
| S167 | 2010-07-30 | Real-time Process |
| S166 | 2010-07-29 | 30-day Notice |
| S165 | 2010-07-26 | Real-time Process |
| S164 | 2010-07-19 | 30-day Notice |
| S163 | 2010-07-19 | 30-day Notice |
| S162 | 2010-07-13 | Normal 180 Day Track No User Fee |
| S161 | 2010-07-07 | 30-day Notice |
| S160 | 2010-07-06 | 30-day Notice |
| S159 | 2010-07-06 | Real-time Process |
| S158 | 2010-06-30 | Real-time Process |
| S157 | 2010-07-22 | Real-time Process |
| S156 | 2010-06-24 | Special (immediate Track) |
| S155 | 2010-06-22 | Real-time Process |
| S154 | 2010-06-17 | 30-day Notice |
| S153 | 2010-06-04 | Normal 180 Day Track |
| S152 | 2010-05-21 | 30-day Notice |
| S151 | 2010-05-21 | 30-day Notice |
| S150 | 2010-05-20 | Normal 180 Day Track |
| S149 | 2010-05-19 | Real-time Process |
| S148 | 2010-04-30 | Real-time Process |
| S147 | 2010-03-26 | 30-day Notice |
| S146 | 2010-02-05 | Normal 180 Day Track |
| S145 | 2010-02-04 | 30-day Notice |
| S144 | 2010-01-25 | 135 Review Track For 30-day Notice |
| S143 | 2009-12-24 | 30-day Notice |
| S142 | 2009-11-25 | Normal 180 Day Track No User Fee |
| S141 | 2009-11-05 | Normal 180 Day Track |
| S140 | 2009-10-29 | 30-day Notice |
| S139 | 2009-10-22 | Real-time Process |
| S138 | 2009-10-19 | 30-day Notice |
| S137 | 2009-10-02 | 135 Review Track For 30-day Notice |
| S136 | 2009-09-14 | 30-day Notice |
| S135 | 2009-09-14 | Real-time Process |
| S134 | 2009-09-02 | 30-day Notice |
| S133 | 2009-09-01 | Real-time Process |
| S132 | 2009-08-28 | 30-day Notice |
| S131 | 2009-08-04 | Normal 180 Day Track |
| S130 | 2009-07-16 | Normal 180 Day Track |
| S129 | 2009-06-23 | 30-day Notice |
| S128 | 2009-06-18 | 30-day Notice |
| S127 | 2009-06-10 | 30-day Notice |
| S126 | 2009-05-21 | 30-day Notice |
| S125 | 2009-05-11 | 30-day Notice |
| S124 | ||
| S123 | 2009-04-08 | Real-time Process |
| S122 | 2009-04-02 | Real-time Process |
| S121 | 2009-03-30 | 30-day Notice |
| S120 | 2009-03-23 | Real-time Process |
| S119 | 2009-03-04 | Real-time Process |
| S118 | 2009-02-17 | Real-time Process |
| S117 | 2009-02-10 | Real-time Process |
| S116 | 2009-02-06 | Normal 180 Day Track No User Fee |
| S115 | 2009-01-30 | 30-day Notice |
| S114 | 2009-01-21 | Normal 180 Day Track No User Fee |
| S113 | 2009-01-02 | Real-time Process |
| S112 | 2008-12-31 | Real-time Process |
| S111 | 2008-11-28 | Real-time Process |
| S110 | 2008-11-24 | Real-time Process |
| S109 | 2008-11-13 | Real-time Process |
| S108 | 2008-11-07 | 30-day Notice |
| S107 | 2008-10-22 | Real-time Process |
| S106 | 2008-10-15 | Real-time Process |
| S105 | 2008-09-11 | 30-day Notice |
| S104 | 2008-09-04 | Normal 180 Day Track No User Fee |
| S103 | 2008-08-19 | Real-time Process |
| S102 | 2008-08-11 | 30-day Notice |
| S101 | 2008-08-11 | 30-day Notice |
| S100 | 2008-08-11 | Special (immediate Track) |
| S099 | 2008-07-30 | Real-time Process |
| S098 | 2008-07-24 | 135 Review Track For 30-day Notice |
| S097 | 2008-07-17 | Real-time Process |
| S096 | 2008-06-17 | Real-time Process |
| S095 | 2008-06-13 | 30-day Notice |
| S094 | 2008-06-02 | Real-time Process |
| S093 | 2008-05-30 | Real-time Process |
| S092 | 2008-05-28 | Real-time Process |
| S091 | 2008-05-23 | 30-day Notice |
| S090 | 2008-05-22 | 30-day Notice |
| S089 | 2008-05-21 | 30-day Notice |
| S088 | 2008-05-09 | Real-time Process |
| S087 | 2008-04-15 | 30-day Notice |
| S086 | 2008-04-10 | Real-time Process |
| S085 | 2008-03-25 | Real-time Process |
| S084 | 2008-03-19 | Real-time Process |
| S083 | 2008-03-10 | Real-time Process |
| S082 | 2008-02-12 | Special (immediate Track) |
| S081 | 2008-02-06 | Real-time Process |
| S080 | 2008-02-04 | 30-day Notice |
| S079 | 2008-02-01 | Normal 180 Day Track No User Fee |
| S078 | 2007-12-26 | 30-day Notice |
| S077 | 2007-12-20 | 30-day Notice |
| S076 | 2007-12-13 | 30-day Notice |
| S075 | 2007-12-06 | 30-day Notice |
| S074 | 2007-10-24 | Real-time Process |
| S073 | 2007-10-22 | Real-time Process |
| S072 | 2007-10-19 | Normal 180 Day Track No User Fee |
| S071 | 2007-09-28 | 30-day Notice |
| S070 | 2007-09-21 | Real-time Process |
| S069 | 2007-09-20 | 30-day Notice |
| S068 | 2007-09-13 | 30-day Notice |
| S067 | 2007-09-05 | Normal 180 Day Track |
| S066 | 2007-08-30 | 30-day Notice |
| S065 | 2007-08-23 | 30-day Notice |
| S064 | 2007-08-13 | Real-time Process |
| S063 | 2007-08-13 | Normal 180 Day Track |
| S062 | 2007-07-19 | 30-day Notice |
| S061 | 2007-07-19 | 30-day Notice |
| S060 | 2007-07-19 | 30-day Notice |
| S059 | 2007-06-25 | 30-day Notice |
| S058 | 2007-05-07 | 30-day Notice |
| S057 | 2007-04-25 | 30-day Notice |
| S056 | 2007-04-23 | Normal 180 Day Track |
| S055 | 2007-04-17 | 30-day Notice |
| S054 | 2007-04-16 | 135 Review Track For 30-day Notice |
| S053 | 2007-04-16 | 30-day Notice |
| S052 | 2007-04-13 | Real-time Process |
| S051 | 2007-04-06 | Real-time Process |
| S050 | 2007-04-06 | Normal 180 Day Track |
| S049 | 2007-02-05 | Normal 180 Day Track |
| S048 | 2006-12-21 | 30-day Notice |
| S047 | 2006-12-13 | 30-day Notice |
| S046 | 2006-11-30 | Real-time Process |
| S045 | 2006-11-21 | Real-time Process |
| S044 | 2006-10-25 | 30-day Notice |
| S043 | 2006-10-20 | Real-time Process |
| S042 | 2006-10-18 | 30-day Notice |
| S041 | 2006-10-12 | Real-time Process |
| S040 | 2006-10-06 | Real-time Process |
| S039 | 2006-09-27 | 30-day Notice |
| S038 | ||
| S037 | 2006-09-07 | 30-day Notice |
| S036 | 2006-09-07 | 30-day Notice |
| S035 | 2006-08-28 | 30-day Notice |
| S034 | 2006-07-19 | Normal 180 Day Track |
| S033 | 2006-07-13 | 30-day Notice |
| S032 | 2006-07-03 | 30-day Notice |
| S031 | 2006-06-26 | Real-time Process |
| S030 | 2006-06-07 | Real-time Process |
| S029 | 2006-05-09 | 30-day Notice |
| S028 | 2006-04-26 | 30-day Notice |
| S027 | ||
| S026 | ||
| S025 | 2006-03-30 | Real-time Process |
| S024 | 2006-03-07 | Real-time Process |
| S023 | 2006-02-17 | Normal 180 Day Track |
| S022 | 2006-02-03 | Real-time Process |
| S021 | 2006-01-25 | 30-day Notice |
| S020 | 2005-12-20 | Real-time Process |
| S019 | 2005-11-09 | Normal 180 Day Track |
| S018 | 2005-11-07 | Normal 180 Day Track |
| S017 | 2005-11-03 | 30-day Notice |
| S016 | 2005-10-26 | 135 Review Track For 30-day Notice |
| S015 | 2005-10-24 | Real-time Process |
| S014 | 2005-10-11 | Real-time Process |
| S013 | 2005-10-03 | 30-day Notice |
| S012 | 2005-09-19 | 30-day Notice |
| S011 | 2005-07-29 | Real-time Process |
| S010 | 2005-06-06 | Panel Track |
| S009 | 2005-04-21 | 30-day Notice |
| S008 | 2005-04-18 | Real-time Process |
| S007 | 2005-04-12 | Real-time Process |
| S006 | 2005-03-02 | Real-time Process |
| S005 | 2005-01-24 | Real-time Process |
| S004 | 2004-12-17 | Normal 180 Day Track |
| S003 | 2004-09-27 | Real-time Process |
| S002 | 2004-08-16 | Normal 180 Day Track No User Fee |
| S001 | 2004-07-01 | Normal 180 Day Track |