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 the modification of the indications for the epic and atlas+ hf crt-d systems, specifically the maintenance of synchrony of the left and right ventricles in patients who have undergone an av nodal ablation for chronic (permanent) atrial fibrillation and have nyha class ii or iii heart failure. The st. Jude medical the epic and atlas+ hf crt-d systems are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. In patients indicated for an icd, the epic and atlas+ hf crt-d systems are also intended:1) to provide a reduction of the symptoms of moderate to severe heart failure (nyha functional class iii or iv) in those patients who remain symptomatic despite stable, optimal medical therapy (as defined in the clinical trials section) and have a left ventricular ejection fraction less than or equal to 35% and a prolonged qrs duration 2) to maintain synchrony of the left and right ventricles in patients who have undergone an av nodal ablation for chronic (permanent) atrial fibrillation and have nyha class ii or iii heart failure.
| Device | EPIC AND ATLAS+ HF CRT-D SYSTEMS |
| 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 | 2005-06-06 |
| Decision Date | 2005-11-18 |
| Notice Date | 2005-12-19 |
| PMA | P030054 |
| Supplement | S010 |
| Product Code | NIK |
| Docket Number | 05M-0492 |
| Advisory Committee | Cardiovascular |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | St. Jude Medical 15900 Valley View Ct. sylmar, CA 91342-3577 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
| 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 |