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 modifications to the epic and atlas families of icds and crt-ds, including: addition of an over-current protection circuit; added capability for ram operation with rom backup with defibrillation only (dfo) in the hardware backup mode; addition of daily high-voltage lead impedance measurements; addition of lv ring to rv coil pacing pulse configuration; addition of ventricular intrinsic preference feature; and modifications to programmer software and display enhancements. The devices as modified will be marketed under the trade names promote crt-d device model numbers 3107-36 and 3107-30, and current dr and vr icd device model numbers 2107-36, 2107-30 and 1107-36, 1107-30, and will be supported by the model 3650 merlin pcs with model 3330 version 6. 0 software.
| Device | CURRENT ICD; EPIC HF/ ATLAS + HF FAMILY OF CRT-DS |
| 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 | 2007-04-06 |
| Decision Date | 2007-05-07 |
| PMA | P030054 |
| Supplement | S051 |
| 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 |