Premarket Approval (PMA)

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.

• Device: CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION
• Generic Name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
• Applicant: MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT; 8200 CORAL SEA STREET N.E.; MOUNDS VIEW, MN 55112
• PMA Number: P010031
• Date Received: 05/04/2001
• Decision Date: 06/26/2002
• Product Code: NIK
• Docket Number: 02M-0381
• Notice Date: 08/26/2002
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: Yes
• Combination Product: No
• Recalls: CDRH Recalls

Approval Order Statement  
APPROVAL FOR THE INSYNC ICD MODEL 7272 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WITH CARDIAC RESYNCHRONIZATION THERAPY AND THE MODEL 9969 APPLICATION SOFTWARE. THE INSYNC ICD MODEL 7272 IS INDICATED FOR VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS. THE SYSTEM IS ALSO INDICATED FOR THE 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 QRS DURATION GREATER THAN OR EQUAL TO 130 MS.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 ; S012 S013 S014 S015 S016 S017 S018 S019 S020 S022 S023 S024 ; S025 S026 S028 S029 S031 S032 S033 S034 S035 S036 S037 S038 ; S039 S040 S041 S042 S043 S044 S045 S046 S047 S048 S049 S050 ; S051 S052 S053 S054 S055 S056 S057 S058 S059 S060 S061 S062 ; S063 S064 S065 S066 S067 S068 S069 S070 S071 S072 S073 S074 ; S075 S076 S077 S078 S079 S080 S081 S082 S083 S084 S085 S086 ; S087 S088 S089 S090 S091 S092 S093 S095 S096 S097 S098 S099 ; S100 S101 S102 S103 S104 S105 S106 S107 S108 S109 S110 S111 ; S112 S113 S114 S115 S116 S117 S118 S120 S121 S122 S123 S124 ; S125 S126 S127 S128 S129 S130 S131 S132 S133 S134 S135 S136 ; S137 S138 S139 S140 S141 S142 S143 S144 S145 S146 S147 S148 ; S149 S150 S151 S152 S153 S154 S155 S156 S157 S158 S159 S160 ; S162 S163 S164 S165 S167 S168 S169 S170 S171 S172 S173 S174 ; S175 S176 S177 S178 S179 S180 S181 S182 S183 S184 S185 S186 ; S187 S188 S189 S191 S192 S193 S194 S195 S196 S197 S198 S199 ; S201 S202 S203 S204 S205 S206 S207 S208 S209 S210 S211 S212 ; S213 S214 S215 S216 S217 S218 S219 S220 S221 S222 S223 S224 ; S225 S226 S227 S228 S229 S230 S231 S232 S233 S234 S235 S236 ; S237 S238 S239 S242 S243 S244 S245 S246 S247 S248 S249 S250 ; S251 S252 S253 S254 S255 S256 S257 S258 S259 S260 S261 S262 ; S263 S264 S265 S266 S267 S268 S269 S270 S271 S272 S273 S275 ; S276 S277 S278 S279 S280 S281 S283 S284 S285 S286 S287 S288 ; S289 S290 S291 S292 S293 S294 S295 S296 S297 S298 S299 S300 ; S301 S303 S304 S305 S306 S307 S308 S309 S310 S311 S313 S314 ; S315 S316 S317 S318 S319 S320 S321 S322 S323 S324 S325 S326 ; S327 S328 S329 S330 S331 S332 S333 S334 S335 S336 S338 S339 ; S340 S341 S342 S343 S344 S345 S346 S347 S348 S349 S351 S352 ; S353 S354 S355 S356 S357 S358 S359 S360 S361 S362 S363 S364 ; S365 S366 S367 S368 S369 S370 S371 S372 S373 S374 S375 S376 ; S377 S378 S379 S380 S381 S382 S383 S384 S385 S386 S387 S388 ; S389 S390 S391 S392 S393 S394 S396 S397 S398 S399 S400 S401 ; S402 S403 S404 S406 S407 S408 S409 S410 S411 S412 S413 S414 ; S415 S416 S417 S418 S419 S420 S421 S422 S423 S424 S425 S426 ; S427 S428 S429 S430 S431 S432 S433 S434 S435 S436 S437 S438 ; S439 S440 S441 S442 S443 S444 S445 S446 S447 S448 S449 S450 ; S451 S452 S453 S454 S455 S456 S457 S458 S459 S460 S461 S462 ; S463 S464 S465 S466 S467 S468 S469 S470 S471 S472 S473 S474 ; S475 S476 S477 S478 S479 S480 S481 S482 S483 S484 S485 S486 ; S487 S488 S489 S490 S491 S492 S493 S494 S495 S496 S497 S498 ; S499 S500 S501 S502 S504 S505 S506 S507 S509 S510 S511 S513 ; S514 S515 S516 S517 S518 S519 S520 S521 S522 S523 S524 S525 ; S526 S527 S528 S529 S530 S531 S532 S533 S534 S535 S536 S537 ; S538 S539 S540 S541 S542 S543 S544 S545 S546 S547 S548 S549 ; S550 S551 S552 S553 S554 S555 S556 S557 S558 S559 S560 S561 ; S562 S563 S564 S565 S566 S567 S568 S569 S570 S571 S572 S573 ; S574 S575 S576 S577 S578 S579 S580 S581 S582 S583 S584 S585 ; S586 S587 S588 S589 S590 S592 S593 S594 S595 S596 S597 S598 ; S599 S600 S601 S602 S603 S604 S605 S606 S607 S608 S609 S610 ; S611 S612 S613 S614 S615 S616 S617 S618 S619 S620 S621 S622 ; S623 S624 S625 S626 S627 S628 S629 S630 S631 S632 S633 S634 ; S635 S636 S637 S638 S639 S640 S641 S642 S643 S644 S645 S646 ; S647 S648 S649 S650 S651 S652 S653 S654 S655 S656 S657 S658 ; S659 S660 S661 S662 S663 S664 S665 S666 S667 S668 S669 S670 ; S671 S672 S673 S674 S675 S676 S677 S678 S679 S680 S681 S682 ; S683 S684 S685 S686 S687 S689 S690 S691 S692 S693 S694 S695 ; S696 S697 S698 S699 S700 S701 S702 S703 S704 S705 S706 S707 ; S708 S709 S710 S711 S712 S713 S714 S715 S716 S717 S718 S719 ; S720 S721 S722 S723 S724 S725 S726 S727 S728 S729 S730 S731 ; S732 S733 S734 S735 S736 S737 S738 S739 S740 S741 S742 S743 ; S744 S745 S746 S747 S748 S749 S750 S751 S752 S753 S754 S755 ; S756 S757 S758 S759 S760 S761 S762 S763 S764 S765 S766 S767 ; S768 S769 S770 S771 S772 S773 S774 S775 S776 S777 S779 S780 ; S781 S782 S783 S785 S786 S787 S788 S789 S790 S791 S792 S793 ; S795 S796 S797 S798 S799 S800 S801 S802 S803 S804 S805 S806 ; S808 S809 S810 S811 S812 S813 S814 S815 S816 S817 S818 S819 ; S820 S821 S822 S823 S825 S826 S827 S828 S829 S830 S831 S832 ; S833 S834 S835 S836 S837 S838 S839 S840 S841 S842 S843 S844 ; S845 S846 S848 S849 S850 S851 S852