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: MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM
• Generic Name: Implantable pulse generator, pacemaker (non-CRT)
• Applicant: MEDTRONIC Inc.; 8200 CORAL SEA STREET NE; MS MV S11; MOUNDS VIEW, MN 55112
• PMA Number: P010015
• Date Received: 03/02/2001
• Decision Date: 08/28/2001
• Product Code: LWP
• Docket Number: 01M-0373
• Notice Date: 08/30/2001
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: Yes
• Combination Product: No
• Recalls: CDRH Recalls

Approval Order Statement  
APPROVAL FOR THE MEDTRONIC INSYNC BIVENTRICULAR PACING SYSTEM INCLUDING THE MODEL 8040 INSYNC PULSE GENERATOR, THE MODEL 9980 PROGRAMMER SOFTWARE, AND THE ATTAIN LV MODEL 2187 AND ATTAIN CS MODEL 2188 LEADS. THE PULSE GENERATOR AND LEADS ARE INDICATED AS FOLLOWS: 1) THE INSYNC MODEL 8040 PULSE GENERATOR IS INDICATED FOR THE REDUCTION OF THE SYMPTOMS OF MODERATE TO SECERE HEART FAILURE (NYHA FUNCTIONAL CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL, MEDICAL THERAPY, AND HAVE A LEFT VENTRICULAR EJECTION FRACTION <= 35% AND A QRS DURATION = 130 MS. 2) THE ATTAIN LV MODEL 2187 LEAD HAS APPLICATION AS PART OF A MEDTRONIC BIVENTRICULAR PACING SYSTEM. 3) THE ATTAIN CS MODEL 2188 LEAD HAS APPLICATION WHERE PERMANENT ATRIAL, OR FUAL-CHAMBER PACING SYSTEMS ARE INDICATED, OR AS PART OF A MEDTRONIC BIVENTRICULAR PACING SYSTEM.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Post-Approval Study: Show Report Schedule and Study Progress
• Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 ; S012 S013 S014 S016 S018 S019 S020 S021 S022 S023 S024 S025 ; S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 ; S038 S039 S041 S042 S043 S044 S045 S046 S047 S048 S049 S050 ; S051 S053 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 S092 S093 S094 S095 S096 S098 S099 S101 S102 S103 ; S104 S105 S106 S107 S108 S109 S111 S112 S113 S114 S115 S116 ; S117 S118 S119 S120 S121 S122 S123 S124 S125 S127 S128 S129 ; S130 S131 S132 S133 S134 S135 S136 S137 S138 S139 S140 S141 ; S142 S143 S144 S145 S146 S148 S149 S150 S151 S152 S154 S155 ; S156 S157 S158 S159 S160 S162 S163 S164 S165 S166 S167 S168 ; S169 S170 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 S200 S201 S202 S203 S204 ; S205 S206 S207 S208 S209 S210 S211 S212 S213 S214 S215 S217 ; S218 S219 S220 S221 S222 S223 S224 S225 S226 S227 S228 S229 ; S230 S231 S232 S233 S234 S235 S236 S237 S238 S239 S240 S241 ; 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 S274 S275 S276 S277 ; S278 S279 S280 S282 S283 S284 S285 S286 S287 S288 S289 S290 ; S291 S292 S293 S294 S295 S296 S297 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 S336 S337 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 S395 S396 S397 S398 S399 ; S400 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 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 S499 S500 S501 S502 S503 S504 S505 S506 S507 S508 ; S509 S510 S511 S512 S513 S514 S515 S516 S517 S518 S519 S520 ; S521 S522 S523 S524 S525 S526 S527 S528 S529 S530 S531 S532 ; S533 S534 S535