| Device | Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ |
| Generic Name | Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d) |
| Applicant | Abbott Medical |
| Date Received | 2021-10-18 |
| Decision Date | 2022-01-07 |
| PMA | P030054 |
| Supplement | S396 |
| 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 | Abbott Medical 15900 Valley View Court sylmar, CA 91335 |
| 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 |