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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.
Classification Namepulse generator, permanent, implantable
Generic Namepulse generator, permanent, implantable
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[ Registered Establishments with NVZ ]
Docket Number 99M-2671
Notice Date 08/17/1999
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Recalls CDRH 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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
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S284 S285 S286 S287 S288 S289 S290 S291 S292 
S293 S294 S295 S296 S297 S298 S299 S300 S301 
S303 S304 S305 S306 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 S336 S337 S338 S339 S340 
S341 S342 S343 S344 S345 S346 S347 S348 S349 
S350 S351 S352 S353 S354 S355 S356 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 S395 
S396 S397 S398 S401 S402 S403 S404 S405 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 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 S498 
S499 S500 S501 S502 S503 S504 S505 S506 S507 
S508 S509 S510 S511 S512 S513 S514 S515 S516 
S517 S520 S521 S522