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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.
 
DeviceMEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE
Generic Namepulse generator, permanent, implantable
ApplicantMEDTRONIC Inc.
8200 coral sea street ne
ms mv s11
mounds view, MN 55112
PMA NumberP980035
Date Received08/25/1998
Decision Date01/29/1999
Product Code NVZ 
Docket Number 99M-2671
Notice Date 08/17/1999
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the Medtronic.Kappa(TM) 700/600 Series Pacemakers, which include; Medtronic.Kappa(TM) Kdr 701, 703, 706, 721, 731, 733, 601, 603, and 606; Kd 701, 703, and 706; Kvdd 701; and Ksr 701, 703, and 706 implantable pacemakers with Medtronic.Vision (Model 9953E) Software. These devices are indicated for the following: Rate adaptive pacing in patients who may benefit from increase pacing rates concurrent with increases in activity; Accepted patient conditions warranting chronic cardiac pacing which include: - Symptomatic parosysmal or permanents second or third-degree AV block; - Symptomatic bilateral bundle branch block; - Symptomatic paroxysmal or transient sinus node dysfunctions with or without assocated AV conduction disorders; - Bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias; - Vasovagal syndromes or hypersensitive carotid sinus syndromes. In addition, Medtronic.Kappa(TM) 700/600 Series pacemakers are also indicated for dual chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and AV synchrony, which include: -various degrees of AV block to maintain the atrial contribution to cardiac output; -VVI intolerance (e.g., pacemaker syndrome) in the presence of persistent sinus rhythm. Medtronic.Kappa(TM) 700/600 Series pacemakers are also indicated for VDD modes in patients having adequate atrial rates and the following indications: - Requirements for ventricular pacing when adequate atrial rates and adequate intracavitary atrial complexes are present. This includes the presence of complete AV block when atrial contribution is needed for hemodynamic benefit or when pacemaker syndrome has existed or is anticipated. Normal sinus rhythm and normal AV conduction in patients needing ventricular pacing intermittently.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements: S488 S489 S490 S491 S492 S493 S494 S155 S156 S157 S158 S159 
S160 S161 S476 S477 S478 S479 S480 S481 S482 S483 S495 S496 
S498 S499 S500 S501 S502 S503 S504 S505 S506 S507 S200 S201 
S202 S203 S204 S205 S206 S404  S339 S340 S341 S342 S343 
S344 S258 S260 S261 S388 S389 S390 S391 S392 S393 S300 S301 
S303 S355 S286 S287 S288 S289 S290 S405 S406 S407 S408 S410 
S409 S411 S412 S413 S414 S425 S426 S427 S428 S429 S430 S431 
S162 S163 S164 S165 S166 S167 S168 S169 S170 S007 S008 S004 
S005 S001 S002 S003 S009 S363 S364 S365 S366 S020 S021 S022 
S023 S024 S025 S026 S027 S028 S262 S263 S264 S265 S266 S267 
S268 S270 S374 S375 S376 S377 S378 S047 S049 S050 S051 S052 
S053 S054 S055 S056 S057 S058 S059 S060 S061 S062 S063 S064 
S065 S066 S067 S068 S069 S070 S071 S224 S225 S226 S227 S229 
S230 S231 S081 S082 S083 S084 S085 S086 S087 S088 S089 S090 
S091 S092 S093 S094 S095 S096 S097 S098 S099 S100 S101 S102 
S103 S104 S105 S106 S107 S108 S109 S110 S111 S112 S114 S115 
S116 S117 S118 S119 S120 S122 S123 S124 S125 S126 S240 S137 
S150 S151 S152 S153 S154 S241 S242 S243 S244 S245 S246 S247 
S248 S249 S250 S252 S253 S171 S172 S173 S174 S175 S176 S177 
S178 S179 S180 S181 S182 S183 S184 S185 S186 S187 S188 S189 
S190 S191 S192 S193 S194 S195 S196 S197 S198 S199 S452 S453 
S454 S455 S456 S457 S458 S459 S460 S461 S462 S463 S464 S465 
S466 S467 S468 S469 S470 S471 S472 S473 S474 S475 S440 S441 
S442 S443 S444 S445 S446 S356 S358 S359 S360 S361 S362 S304 
S305 S306 S308 S309 S310 S311 S312 S313 S277 S278 S279 S280 
S281 S282 S283 S284 S285 S314 S315 S316 S317 S394 S395 S396 
S397 S398 S318 S319 S320 S321 S322 S323 S324 S325 S327 S326 
S328 S329 S079 S080 S072 S039 S040 S041 S077 S078 S029 S030 
S016 S017 S018 S019 S147 S148 S149 S006 S075 S076 S011 S012 
S013 S014 S015 S043 S044 S045 S046 S127 S128 S129 S130 S131 
S132 S133 S134 S136 S031 S032 S033 S034 S035 S036 S037 S038 
S073 S074 S010 S138 S139 S140 S141 S142 S143 S145 S146 S432 
S433 S434 S435 S436 S437 S438 S415 S416 S417 S418 S419 S420 
S421 S422 S423 S424 S401 S402 S403 S379 S380 S381 S382 S383 
S384 S385 S386 S387 S367 S368 S369 S371 S370 S373 S372 S330 
S331 S332 S333 S334 S336 S337 S338 S275 S271 S272 S273 S274 
S276 S257 S298 S299 S254 S255 S345 S346 S347 S348 S349 S350 
S351 S352 S353 S354 S447 S448 S449 S450 S451 S291 S292 S293 
S294 S295 S296 S297 S223 S222 S207 S208 S209 S211 S213 S214 
S215 S216 S217 S218 S219 S220 S221 S232 S233 S234 S235 S236 
S237 S238 S239 S725 S726 S727 S728 S729 S730 S718 S719 S720 
S721 S722 S723 S724 S731 S732 S733 S734 S735 S697 S698 S699 
S484 S485 S486 S487 S508 S509 S510 S511 S512 S513 S514 S515 
S516 S517 S518 S519 S520 S521 S522 S523 S524 S525 S526 S527 
S528 S529 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 S591 S592 S593 S594 S595 S596 S597 S598 S599 S600 
S601 S602 S603 S604 S605 S606 S607 S608 S609 S610 S611 S612 
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 S688 S689 S690 S691 S692 S693 S694 S695 S696 S700 
S701 S702 S703 S704 S705 S706 S707 S708 S709 S710 S711 S712 
S713 S714 S715 S717 
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