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.
Acceptance to add an alternate supplier of connector assemblies that will be mounted on the hybrids for icd and crt-d devices.
| Device | Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF, |
| Generic Name | Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d) |
| Applicant | Abbott Medical |
| Date Received | 2021-08-04 |
| Decision Date | 2021-09-01 |
| PMA | P030054 |
| Supplement | S395 |
| Product Code | NIK |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |