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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceCONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantBoston Scientific Corp.
4100 HAMLINE AVE NORTH
ST. PAUL, MN 55112
PMA NumberP010012
Date Received02/27/2001
Decision Date05/02/2002
Product Code NIK 
Docket Number 02M-0236
Notice Date 05/22/2002
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
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
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements: S184 S185 S186 S187 S188 S189 S190 S447 S448 S234 S235 S237 
S238 S239 S240 S241 S242 S243 S457 S458 S435 S436 S437 S486 
S021 S022 S023 S024 S025 S026 S027 S029 S030 S031 S014 S015 
S016 S017 S018 S019 S150 S151 S152 S153 S217 S218 S219 S260 
S010 S011 S012 S013 S134 S001 S002 S003 S004 S506 S507 S508 
S410 S411 S412 S413 S414 S261 S262 S264 S265 S266 S267 S268 
S269 S270 S271 S272 S273 S274 S275 S276 S277 S278 S279 S280 
S281 S282 S283 S284 S285 S286 S287 S288 S289 S290 S291 S292 
S293 S294 S295 S296 S297 S345 S346 S347 S348 S349 S350 S351 
S352 S353 S354 S355 S356 S357 S358 S359 S361 S360 S362 S363 
S364 S365 S366 S368 S369 S370 S371 S372 S373 S374 S375 S376 
S377 S379 S378 S380 S381 S382 S383 S384 S385 S386 S387 S388 
S389 S390 S391 S394 S395 S396 S397 S398 S399 S400 S401 S402 
S403 S404 S405 S406 S407 S408 S409 S415 S416 S417 S418  
S443 S444 S445 S446 S298 S299 S300 S301 S302 S303 S304 S305 
S306 S307 S308 S309 S310 S311 S312 S313 S314 S315 S316 S317 
S318 S319 S320 S321 S322 S323 S324 S325 S326 S327 S328 S329 
S330 S331 S332 S333 S334 S335 S337 S338 S339 S340 S341 S342 
S222 S223 S224 S225 S226 S227 S228 S229 S230 S231 S232 S233 
S343 S344 S194 S449 S450 S451 S452 S453 S454 S455 S456 S430 
S431 S419 S420 S421 S422 S423 S076 S077 S078 S079 S080 S081 
S084 S085 S087 S088 S089 S090 S091 S092 S094 S095 S096 S097 
S098 S099 S100 S101 S102 S103 S032 S033 S034 S036 S037 S038 
S040 S041 S042 S043 S044 S045 S046 S165 S166 S167 S104 S105 
S106 S107 S108 S109 S110 S111 S112 S113 S114 S115 S116 S117 
S118 S119 S120 S121 S122 S123 S125 S126 S128 S129 S130 S131 
S132 S133 S215 S216 S047 S048 S049 S050 S051 S052 S053 S054 
S055 S056 S057 S059 S061 S062 S064 S065 S066 S067 S068 S069 
S070 S072 S073 S074 S139 S203 S204 S205 S206 S207 S208 S209 
S210 S211 S212 S213 S214 S424 S425 S426 S427 S428 S429 S438 
S439 S440 S441 S442 S432 S433 S434 S005 S006 S007 S008 S009 
S154 S155 S156 S157 S158 S159 S160 S161 S162 S163 S168 S169 
S170 S171 S172 S140 S142 S143 S244 S245 S246 S247 S248 S249 
S250 S251 S252 S253 S254 S255 S257 S258 S173 S174 S175 S176 
S220 S191 S192 S193 S144 S145 S146 S147 S148 S149 S177 S178 
S179 S180 S181 S182 S183 S195 S196 S197 S198 S199 S200 S202 
S467 S468 S469 S470 S471 S472 S479 S480 S481 S496 S497 S498 
S499 S510 S511 S514 S515 S516 S528 S529 S530 S500 S501 S490 
S552 S565 S566 S539 S540 S550 S551 S553 S533 S534 S535 S568 
S587 S588 S580 S581 S461 S462 S463 S464 S465 S466 S483 S484 
S485 S473 S474 S475 S476 S477 S478 S487 S488 S459 S460 S482 
S502 S503 S504 S492 S493 S494 S495 S509 S521 S522 S524 S525 
S526 S527 S517 S518 S519 S520 S505 S523 S512 S513 S489 S491 
S544 S545 S546 S547 S557 S558 S569 S570 S571 S531 S532 S572 
S573 S574 S575 S559 S560 S562 S563 S564 S536 S537 S538 S567 
S548 S549 S541 S542 S543 S554 S555 S556 S589 S579 S585 S586 
S582 S583 S584 S590 S576 S577 S578 
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