Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR

FDA Premarket Approval P980035 S639

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Implementation of modifications to select manufacturing processes of the backfill hole weld

DeviceAdapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR
Generic NamePulse Generator, Permanent, Implantable
ApplicantMEDTRONIC Inc.
Date Received2020-08-28
Decision Date2020-09-18
PMAP980035
SupplementS639
Product CodeNVZ 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address MEDTRONIC Inc. 8200 Coral Sea Street Ne ms Mv S11 mounds View, MN 55112

Supplemental Filings

Supplement NumberDateSupplement Type
P980035Original Filing
S656 2020-10-19 30-day Notice
S655
S654 2020-10-15 30-day Notice
S653
S652 2020-10-02 30-day Notice
S651
S650
S649
S648
S647 2020-09-14 30-day Notice
S646
S645
S644 2020-09-14 30-day Notice
S643 2020-09-11 30-day Notice
S642 2020-09-04 30-day Notice
S641 2020-09-04 30-day Notice
S640 2020-09-03 30-day Notice
S639 2020-08-28 30-day Notice
S638
S637
S636 2020-07-27 30-day Notice
S635 2020-07-14 30-day Notice
S634 2020-07-09 30-day Notice
S633 2020-07-06 30-day Notice
S632 2020-07-02 30-day Notice
S631 2020-06-26 30-day Notice
S630 2020-06-16 30-day Notice
S629
S628
S627 2020-05-15 30-day Notice
S626 2020-04-27 30-day Notice
S625 2020-04-08 30-day Notice
S624 2020-03-25 30-day Notice
S623 2020-03-16 30-day Notice
S622 2020-03-16 30-day Notice
S621 2020-03-12 30-day Notice
S620 2020-03-02 30-day Notice
S619
S618
S617 2020-02-24 30-day Notice
S616
S615 2020-02-20 30-day Notice
S614 2019-12-23 Real-time Process
S613 2019-12-20 30-day Notice
S612 2019-12-11 30-day Notice
S611 2019-12-10 30-day Notice
S610 2019-11-25 30-day Notice
S609 2019-11-18 30-day Notice
S608
S607 2019-11-06 30-day Notice
S606 2019-10-08 30-day Notice
S605 2019-09-16 30-day Notice
S604 2019-08-01 30-day Notice
S603 2019-07-29 30-day Notice
S602 2019-07-12 30-day Notice
S601
S600 2019-07-01 30-day Notice
S599 2019-06-20 30-day Notice
S598 2019-06-11 30-day Notice
S597 2019-06-10 30-day Notice
S596 2019-05-30 30-day Notice
S595
S594
S593 2019-05-06 30-day Notice
S592 2019-04-29 30-day Notice
S591 2019-04-29 30-day Notice
S590 2019-04-23 30-day Notice
S589 2019-04-11 30-day Notice
S588 2019-04-08 30-day Notice
S587
S586 2019-04-03 30-day Notice
S585 2019-03-28 30-day Notice
S584
S583
S582
S581
S580 2019-03-05 30-day Notice
S579 2019-03-04 30-day Notice
S578 2019-02-26 30-day Notice
S577 2019-02-25 30-day Notice
S576 2019-02-05 Real-time Process
S575 2019-01-23 30-day Notice
S574 2018-12-10 30-day Notice
S573 2018-11-16 30-day Notice
S572 2018-11-08 30-day Notice
S571 2018-11-05 30-day Notice
S570 2018-11-01 30-day Notice
S569 2018-10-26 30-day Notice
S568 2018-10-23 30-day Notice
S567 2018-10-18 30-day Notice
S566 2018-10-15 30-day Notice
S565 2018-10-09 30-day Notice
S564 2018-09-26 30-day Notice
S563 2018-09-13 30-day Notice
S562 2018-08-29 30-day Notice
S561 2018-08-22 Real-time Process
S560 2018-08-08 30-day Notice
S559 2018-08-06 30-day Notice
S558 2018-06-28 Normal 180 Day Track No User Fee
S557 2018-05-17 30-day Notice
S556 2018-05-15 30-day Notice
S555 2018-05-14 30-day Notice
S554 2018-05-11 30-day Notice
S553 2018-05-08 30-day Notice
S552 2018-04-25 30-day Notice
S551 2018-04-23 30-day Notice
S550 2018-04-17 Real-time Process
S549 2018-04-13 Normal 180 Day Track
S548 2018-04-12 30-day Notice
S547 2018-04-12 30-day Notice
S546 2018-04-09 30-day Notice
S545 2018-04-06 30-day Notice
S544 2018-03-30 30-day Notice
S543 2018-03-22 30-day Notice
S542 2018-03-22 30-day Notice
S541 2018-03-14 30-day Notice
S540 2018-03-12 30-day Notice
S539 2018-03-12 30-day Notice
S538 2018-03-09 30-day Notice
S537 2018-03-05 30-day Notice
S536 2018-02-12 Normal 180 Day Track
S535 2018-02-08 30-day Notice
S534 2018-02-01 Real-time Process
S533 2018-02-01 30-day Notice
S532 2018-01-29 Real-time Process
S531 2018-01-24 30-day Notice
S530
S529 2017-11-29 30-day Notice
S528 2017-11-20 30-day Notice
S527 2017-11-13 30-day Notice
S526 2017-11-13 30-day Notice
S525 2017-11-07 30-day Notice
S524 2017-11-01 30-day Notice
S523 2017-10-16 30-day Notice
S522 2017-10-06 30-day Notice
S521 2017-09-28 30-day Notice
S520 2017-09-19 30-day Notice
S519 2017-09-05 Real-time Process
S518 2017-08-31 Normal 180 Day Track
S517 2017-08-04 30-day Notice
S516 2017-07-20 30-day Notice
S515 2017-07-20 30-day Notice
S514 2017-07-19 30-day Notice
S513 2017-07-14 Real-time Process
S512 2017-06-27 30-day Notice
S511 2017-06-23 30-day Notice
S510 2017-06-16 30-day Notice
S509 2017-06-08 30-day Notice
S508 2017-06-07 30-day Notice
S507 2017-05-18 30-day Notice
S506 2017-05-18 Normal 180 Day Track
S505 2017-05-15 30-day Notice
S504 2017-05-12 30-day Notice
S503 2017-05-12 30-day Notice
S502 2017-05-12 30-day Notice
S501 2017-05-10 30-day Notice
S500 2017-05-10 30-day Notice
S499 2017-05-10 30-day Notice
S498 2017-05-05 30-day Notice
S497
S496 2017-04-04 30-day Notice
S495 2017-04-03 Normal 180 Day Track
S494 2017-03-31 30-day Notice
S493 2017-03-29 30-day Notice
S492 2017-03-13 30-day Notice
S491 2017-03-08 30-day Notice
S490 2017-02-09 30-day Notice
S489 2017-02-03 30-day Notice
S488 2017-02-03 30-day Notice
S487 2017-01-13 30-day Notice
S486 2016-12-06 Normal 180 Day Track
S485 2016-11-23 Real-time Process
S484 2016-11-22 30-day Notice
S483 2016-11-16 Normal 180 Day Track
S482 2016-11-14 30-day Notice
S481 2016-11-02 Normal 180 Day Track
S480 2016-10-31 30-day Notice
S479 2016-10-17 30-day Notice
S478 2016-09-30 Real-time Process
S477 2016-09-28 30-day Notice
S476 2016-09-26 30-day Notice
S475 2016-09-12 Normal 180 Day Track
S474 2016-09-08 Real-time Process
S473 2016-08-17 30-day Notice
S472 2016-07-22 30-day Notice
S471 2016-07-13 Real-time Process
S470 2016-06-29 Normal 180 Day Track
S469 2016-06-24 Real-time Process
S468 2016-06-24 30-day Notice
S467 2016-06-22 30-day Notice
S466 2016-06-13 30-day Notice
S465 2016-06-09 30-day Notice
S464 2016-03-11 Normal 180 Day Track
S463 2016-04-25 30-day Notice
S462 2016-04-11 30-day Notice
S461 2016-03-31 30-day Notice
S460 2016-03-18 Real-time Process
S459 2016-03-17 30-day Notice
S458 2016-02-29 30-day Notice
S457 2016-02-25 30-day Notice
S456 2016-02-25 30-day Notice
S455 2016-02-05 30-day Notice
S454 2016-02-02 30-day Notice
S453 2016-01-19 30-day Notice
S452 2016-01-12 Real-time Process
S451 2015-12-28 30-day Notice
S450 2015-12-18 Real-time Process
S449 2015-12-16 30-day Notice
S448 2015-12-04 30-day Notice
S447 2015-12-01 Normal 180 Day Track
S446 2015-10-22 Real-time Process
S445 2015-10-22 Real-time Process
S444 2015-10-19 30-day Notice
S443 2015-10-16 Real-time Process
S442 2015-10-13 Normal 180 Day Track
S441 2015-09-30 30-day Notice
S440 2015-09-30 30-day Notice
S439
S438 2015-08-31 30-day Notice
S437 2015-08-28 Real-time Process
S436 2015-08-12 30-day Notice
S435 2015-08-11 30-day Notice
S434 2015-08-05 30-day Notice
S433 2015-07-20 30-day Notice
S432 2015-07-09 30-day Notice
S431 2015-07-02 Real-time Process
S430 2015-07-01 30-day Notice
S429 2015-07-01 30-day Notice
S428 2015-06-19 30-day Notice
S427 2015-06-03 30-day Notice
S426 2015-06-01 30-day Notice
S425 2015-05-22 30-day Notice
S424 2015-04-20 Normal 180 Day Track
S423 2015-04-17 30-day Notice
S422 2015-04-16 30-day Notice
S421 2015-04-14 Real-time Process
S420 2015-03-26 Real-time Process
S419 2015-03-24 30-day Notice
S418 2015-03-24 30-day Notice
S417 2015-03-23 30-day Notice
S416 2015-03-23 30-day Notice
S415 2015-03-06 Real-time Process
S414 2015-02-06 30-day Notice
S413 2015-02-05 30-day Notice
S412 2015-02-05 30-day Notice
S411 2015-02-04 30-day Notice
S410 2015-02-02 30-day Notice
S409 2015-02-02 30-day Notice
S408 2015-01-29 30-day Notice
S407 2015-01-23 30-day Notice
S406 2015-01-22 30-day Notice
S405 2015-01-20 30-day Notice
S404 2014-12-22 Normal 180 Day Track
S403 2014-12-05 30-day Notice
S402 2014-12-04 30-day Notice
S401 2014-11-19 30-day Notice
S400
S399
S398 2014-10-14 30-day Notice
S397 2014-10-07 30-day Notice
S396 2014-10-02 30-day Notice
S395 2014-09-19 30-day Notice
S394 2014-09-09 30-day Notice
S393 2014-08-27 30-day Notice
S392 2014-08-27 Real-time Process
S391 2014-08-19 Real-time Process
S390 2014-08-18 30-day Notice
S389 2014-08-06 30-day Notice
S388 2014-08-01 30-day Notice
S387 2014-07-25 30-day Notice
S386 2014-07-24 30-day Notice
S385 2014-07-23 30-day Notice
S384 2014-07-18 Normal 180 Day Track
S383 2014-07-07 30-day Notice
S382 2014-07-02 Real-time Process
S381 2014-06-19 30-day Notice
S380 2014-06-13 30-day Notice
S379 2014-06-06 30-day Notice
S378 2014-05-23 30-day Notice
S377 2014-05-08 30-day Notice
S376 2014-05-01 30-day Notice
S375 2014-04-25 30-day Notice
S374 2014-04-23 Normal 180 Day Track
S373 2014-03-28 Real-time Process
S372 2014-03-28 Real-time Process
S371 2014-03-20 30-day Notice
S370 2014-03-20 30-day Notice
S369 2014-03-18 Real-time Process
S368 2014-03-07 30-day Notice
S367 2014-02-27 30-day Notice
S366 2014-01-30 30-day Notice
S365 2014-01-29 30-day Notice
S364 2014-01-27 30-day Notice
S363 2014-01-22 30-day Notice
S362 2013-12-24 30-day Notice
S361 2013-12-23 30-day Notice
S360 2013-12-19 Real-time Process
S359 2013-12-19 30-day Notice
S358 2013-12-18 Normal 180 Day Track
S357
S356 2013-12-12 30-day Notice
S355 2013-11-19 30-day Notice
S354 2013-10-24 30-day Notice
S353 2013-10-24 30-day Notice
S352 2013-10-23 30-day Notice
S351 2013-10-21 30-day Notice
S350 2013-10-17 30-day Notice
S349 2013-10-17 30-day Notice
S348 2013-09-26 30-day Notice
S347 2013-09-24 30-day Notice
S346 2013-09-17 30-day Notice
S345 2013-09-11 30-day Notice
S344 2013-09-03 30-day Notice
S343 2013-08-23 Normal 180 Day Track
S342 2013-08-21 30-day Notice
S341 2013-08-12 Real-time Process
S340 2013-07-26 30-day Notice
S339 2013-07-17 30-day Notice
S338 2013-07-08 Normal 180 Day Track
S337 2013-07-02 30-day Notice
S336 2013-06-24 30-day Notice
S335
S334 2013-06-11 Normal 180 Day Track
S333 2013-06-07 30-day Notice
S332 2013-06-07 30-day Notice
S331 2013-05-30 30-day Notice
S330 2013-05-29 30-day Notice
S329 2013-05-21 30-day Notice
S328 2013-05-17 30-day Notice
S327 2013-05-17 Real-time Process
S326 2013-05-16 Real-time Process
S325 2013-05-13 Real-time Process
S324 2013-05-10 30-day Notice
S323 2013-04-25 30-day Notice
S322 2013-04-23 30-day Notice
S321 2013-04-18 Real-time Process
S320 2013-04-17 Real-time Process
S319 2013-04-10 Normal 180 Day Track No User Fee
S318 2013-04-09 30-day Notice
S317 2013-03-27 Real-time Process
S316 2013-03-27 30-day Notice
S315 2013-03-13 30-day Notice
S314 2013-03-11 30-day Notice
S313 2013-03-05 30-day Notice
S312 2013-03-04 30-day Notice
S311 2013-02-26 Normal 180 Day Track
S310 2013-02-21 30-day Notice
S309 2013-02-21 30-day Notice
S308 2013-02-07 30-day Notice
S307
S306 2013-01-29 30-day Notice
S305 2013-01-25 30-day Notice
S304 2013-01-22 30-day Notice
S303 2013-01-14 30-day Notice
S302
S301 2012-11-21 30-day Notice
S300 2012-11-15 30-day Notice
S299 2012-11-05 30-day Notice
S298 2012-11-01 Real-time Process
S297 2012-10-19 30-day Notice
S296 2012-10-19 Real-time Process
S295 2012-10-05 30-day Notice
S294 2012-09-26 30-day Notice
S293 2012-09-21 30-day Notice
S292 2012-09-10 30-day Notice
S291 2012-09-07 30-day Notice
S290 2012-08-24 Real-time Process
S289 2012-08-21 30-day Notice
S288 2012-08-21 30-day Notice
S287 2012-08-13 30-day Notice
S286 2012-08-08 30-day Notice
S285 2012-08-03 30-day Notice
S284 2012-07-31 30-day Notice
S283 2012-07-25 30-day Notice
S282 2012-07-25 30-day Notice
S281 2012-07-23 30-day Notice
S280 2012-07-17 Normal 180 Day Track
S279 2012-07-13 30-day Notice
S278 2012-07-11 30-day Notice
S277 2012-06-29 Normal 180 Day Track
S276 2012-06-29 30-day Notice
S275 2012-06-29 Real-time Process
S274 2012-06-12 30-day Notice
S273 2012-06-08 30-day Notice
S272 2012-08-21 Normal 180 Day Track
S271 2012-05-17 30-day Notice
S270 2012-08-21 Normal 180 Day Track
S269
S268 2012-04-04 Real-time Process
S267 2012-03-27 30-day Notice
S266 2012-03-09 30-day Notice
S265 2012-03-07 30-day Notice
S264 2012-03-07 Normal 180 Day Track
S263 2012-03-05 30-day Notice
S262 2012-02-29 30-day Notice
S261 2012-02-27 Real-time Process
S260 2012-02-13 30-day Notice
S259
S258 2012-02-07 30-day Notice
S257 2012-02-03 30-day Notice
S256
S255 2011-12-20 30-day Notice
S254 2011-11-23 30-day Notice
S253 2011-11-21 Normal 180 Day Track
S252 2011-11-17 135 Review Track For 30-day Notice
S251
S250 2011-11-14 30-day Notice
S249 2011-11-10 Real-time Process
S248 2011-10-26 30-day Notice
S247 2011-10-25 30-day Notice
S246 2011-10-06 30-day Notice
S245 2011-10-05 Real-time Process
S244 2011-09-27 Real-time Process
S243 2011-09-22 30-day Notice
S242 2011-09-19 Real-time Process
S241 2011-09-16 30-day Notice
S240 2011-08-24 30-day Notice
S239 2011-07-20 30-day Notice
S238 2011-07-18 30-day Notice
S237 2011-07-18 30-day Notice
S236 2011-07-08 30-day Notice
S235 2011-07-06 30-day Notice
S234 2011-06-30 30-day Notice
S233 2011-06-29 30-day Notice
S232 2011-06-28 30-day Notice
S231 2011-06-08 30-day Notice
S230 2011-06-07 30-day Notice
S229 2011-05-27 30-day Notice
S228
S227 2011-05-17 Real-time Process
S226 2011-05-13 30-day Notice
S225 2011-05-10 30-day Notice
S224 2011-05-09 30-day Notice
S223 2011-05-05 Normal 180 Day Track No User Fee
S222 2011-04-29 30-day Notice
S221 2011-04-26 30-day Notice
S220 2011-04-25 30-day Notice
S219 2011-04-25 Real-time Process
S218 2011-04-21 30-day Notice
S217 2011-04-19 30-day Notice
S216 2011-04-15 30-day Notice
S215 2011-04-11 30-day Notice
S214 2011-04-05 30-day Notice
S213 2011-04-04 30-day Notice
S212
S211 2011-03-22 135 Review Track For 30-day Notice
S210
S209 2011-03-09 135 Review Track For 30-day Notice
S208 2011-03-08 30-day Notice
S207 2011-03-02 30-day Notice
S206 2011-02-18 30-day Notice
S205 2011-02-16 30-day Notice
S204 2011-02-16 30-day Notice
S203 2011-02-03 30-day Notice
S202 2011-02-01 30-day Notice
S201 2011-01-25 30-day Notice
S200 2011-01-04 Normal 180 Day Track
S199 2010-12-09 30-day Notice
S198 2010-12-08 30-day Notice
S197 2010-12-07 Real-time Process
S196 2010-11-17 30-day Notice
S195 2010-11-15 30-day Notice
S194 2010-11-12 30-day Notice
S193 2010-11-12 30-day Notice
S192 2010-11-09 30-day Notice
S191 2010-10-26 30-day Notice
S190 2010-10-15 30-day Notice
S189 2010-10-12 30-day Notice
S188 2010-09-16 30-day Notice
S187 2010-08-13 30-day Notice
S186 2010-08-10 30-day Notice
S185 2010-07-29 30-day Notice
S184 2010-07-28 30-day Notice
S183 2010-07-26 30-day Notice
S182 2010-07-20 Real-time Process
S181 2010-07-16 30-day Notice
S180 2010-07-15 30-day Notice
S179 2010-07-15 30-day Notice
S178 2010-06-30 30-day Notice
S177 2010-06-28 135 Review Track For 30-day Notice
S176 2010-06-28 30-day Notice
S175 2010-06-25 30-day Notice
S174 2010-06-18 30-day Notice
S173 2010-06-15 Real-time Process
S172 2010-06-10 30-day Notice
S171 2010-06-02 30-day Notice
S170 2010-05-27 30-day Notice
S169 2010-05-20 Real-time Process
S168 2010-05-17 Normal 180 Day Track
S167 2010-05-03 30-day Notice
S166 2010-04-22 Normal 180 Day Track
S165 2010-04-12 30-day Notice
S164 2010-03-31 30-day Notice
S163 2010-03-29 30-day Notice
S162 2010-04-29 Real-time Process
S161 2010-03-01 Real-time Process
S160 2010-02-19 135 Review Track For 30-day Notice
S159 2010-02-18 30-day Notice
S158 2010-02-18 30-day Notice
S157 2010-01-21 30-day Notice
S156 2010-01-13 30-day Notice
S155 2009-12-30 Normal 180 Day Track No User Fee
S154 2009-12-18 30-day Notice
S153 2009-12-16 Normal 180 Day Track
S152 2009-12-08 30-day Notice
S151 2009-12-07 30-day Notice
S150 2009-12-02 Normal 180 Day Track
S149 2009-11-27 30-day Notice
S148 2009-11-23 30-day Notice
S147 2009-11-17 Real-time Process
S146 2009-10-08 Normal 180 Day Track No User Fee
S145 2009-10-08 Real-time Process
S144
S143 2009-09-11 30-day Notice
S142 2009-09-08 30-day Notice
S141 2009-09-08 30-day Notice
S140 2009-07-28 Real-time Process
S139 2009-06-30 30-day Notice
S138 2009-06-17 Real-time Process
S137 2009-06-11 30-day Notice
S136 2009-03-27 Normal 180 Day Track
S135
S134 2009-03-06 Normal 180 Day Track
S133 2009-03-06 30-day Notice
S132 2009-03-05 30-day Notice
S131 2009-03-02 Normal 180 Day Track
S130 2009-02-18 135 Review Track For 30-day Notice
S129 2009-02-13 135 Review Track For 30-day Notice
S128 2009-02-09 135 Review Track For 30-day Notice
S127 2009-02-02 30-day Notice
S126 2008-12-15 30-day Notice
S125 2008-12-11 30-day Notice
S124 2008-12-03 30-day Notice
S123 2008-11-26 30-day Notice
S122 2008-11-20 30-day Notice
S121
S120 2008-11-12 30-day Notice
S119 2008-10-27 Real-time Process
S118 2008-10-17 Real-time Process
S117 2008-09-19 30-day Notice
S116 2008-09-19 30-day Notice
S115 2008-09-17 30-day Notice
S114 2008-09-08 135 Review Track For 30-day Notice
S113
S112 2008-08-18 30-day Notice
S111 2008-08-12 30-day Notice
S110 2008-08-11 30-day Notice
S109 2008-08-11 135 Review Track For 30-day Notice
S108 2008-08-04 135 Review Track For 30-day Notice
S107 2008-07-28 Normal 180 Day Track
S106 2008-07-25 135 Review Track For 30-day Notice
S105 2008-07-23 30-day Notice
S104 2008-07-16 30-day Notice
S103 2008-06-27 135 Review Track For 30-day Notice
S102 2008-06-20 135 Review Track For 30-day Notice
S101 2008-06-20 30-day Notice
S100 2008-06-18 30-day Notice
S099 2008-06-17 Real-time Process
S098 2008-06-02 Normal 180 Day Track No User Fee
S097 2008-06-02 Normal 180 Day Track
S096 2008-05-28 30-day Notice
S095 2008-05-27 135 Review Track For 30-day Notice
S094 2008-05-23 30-day Notice
S093 2008-05-21 30-day Notice
S092 2008-04-14 30-day Notice
S091 2008-03-21 30-day Notice
S090 2008-03-21 30-day Notice
S089 2008-03-06 30-day Notice
S088 2008-03-04 135 Review Track For 30-day Notice
S087 2008-02-26 30-day Notice
S086 2008-01-25 30-day Notice
S085 2007-12-26 135 Review Track For 30-day Notice
S084 2007-12-17 30-day Notice
S083 2007-11-19 30-day Notice
S082 2007-11-19 30-day Notice
S081 2007-11-16 Real-time Process
S080 2007-10-11 30-day Notice
S079 2007-09-28 Normal 180 Day Track
S078 2007-10-09 30-day Notice
S077 2007-09-17 135 Review Track For 30-day Notice
S076 2007-08-23 Special (immediate Track)
S075 2007-07-26 Real-time Process
S074 2007-06-11 Real-time Process
S073 2007-05-10 Real-time Process
S072 2007-03-09 Real-time Process
S071 2006-12-20 Real-time Process
S070 2006-12-14 30-day Notice
S069 2006-12-01 Normal 180 Day Track No User Fee
S068 2006-11-28 Real-time Process
S067 2006-11-28 30-day Notice
S066 2006-10-30 Real-time Process
S065 2006-10-30 Normal 180 Day Track No User Fee
S064 2006-10-17 30-day Notice
S063 2006-10-13 Real-time Process
S062 2006-10-03 Special (immediate Track)
S061 2006-08-21 Normal 180 Day Track No User Fee
S060 2006-08-03 135 Review Track For 30-day Notice
S059 2006-07-21 Real-time Process
S058 2006-07-13 Real-time Process
S057 2006-05-10 135 Review Track For 30-day Notice
S056 2006-03-24 30-day Notice
S055 2006-02-21 Real-time Process
S054 2006-02-14 Real-time Process
S053 2006-01-09 Real-time Process
S052 2005-12-09 Normal 180 Day Track
S051 2005-12-08 Real-time Process
S050 2005-10-26 135 Review Track For 30-day Notice
S049 2005-10-06 135 Review Track For 30-day Notice
S048
S047 2005-09-16 Real-time Process
S046 2005-08-12 Real-time Process
S045 2005-07-26 135 Review Track For 30-day Notice
S044 2005-07-11 Real-time Process
S043 2005-07-01 Normal 180 Day Track
S042
S041 2005-01-27 Normal 180 Day Track No User Fee
S040 2004-11-19 30-day Notice
S039 2004-08-27 30-day Notice
S038 2004-04-27 Normal 180 Day Track
S037 2004-04-16 Normal 180 Day Track No User Fee
S036 2004-03-02 Real-time Process
S035 2004-02-12 Real-time Process
S034 2004-02-11 Normal 180 Day Track No User Fee
S033 2004-01-22 Real-time Process
S032 2003-08-29 Normal 180 Day Track
S031 2003-08-22 Normal 180 Day Track No User Fee
S030 2003-06-05 Normal 180 Day Track
S029 2003-05-12 Real-time Process
S028 2003-05-01 Normal 180 Day Track No User Fee
S027 2003-03-31 Normal 180 Day Track
S026 2003-01-27 Real-time Process
S025 2002-12-03 Normal 180 Day Track
S024 2002-04-08 30-day Notice
S023 2002-03-12 Special (immediate Track)
S022 2002-02-27 Normal 180 Day Track
S021 2002-03-01 Normal 180 Day Track
S020 2002-02-14 Normal 180 Day Track
S019 2002-01-24 Normal 180 Day Track
S018 2002-01-17 30-day Notice
S017 2001-11-30 30-day Notice
S016 2001-11-05 Special (immediate Track)
S015 2001-10-05 Normal 180 Day Track
S014 2001-10-24 Real-time Process
S013 2001-09-17 Panel Track
S012 2001-09-24 30-day Notice
S011 2001-07-16 Normal 180 Day Track
S010 2001-04-13 Special (immediate Track)
S009 2001-02-08 Real-time Process
S008 2000-09-14 Real-time Process
S007 2000-04-10 Real-time Process
S006 1999-12-06 Special (immediate Track)
S005 1999-11-30 Real-time Process
S004 1999-11-11 Real-time Process
S003 1999-05-19 Real-time Process
S002 1999-03-10 Normal 180 Day Track
S001 1999-03-10 Real-time Process

NIH GUDID Devices

Device IDPMASupp
00613994222107 P980035 073
00613994223807 P980035 073
00613994763334 P980035 073
00613994763327 P980035 073
00613994763310 P980035 073
00613994763259 P980035 073
00613994763242 P980035 073
00613994222046 P980035 073
00613994177957 P980035 073
00613994222060 P980035 073
00613994222077 P980035 073
00613994222084 P980035 073
00613994222114 P980035 073
00613994222138 P980035 073
00613994222152 P980035 073
00613994222169 P980035 073
00613994222176 P980035 073
00613994222190 P980035 073
00613994295040 P980035 073
00613994222091 P980035 073
00613994763235 P980035 073
00613994177957 P980035 073
00613994222176 P980035 073
00613994763327 P980035 073
00613994763310 P980035 073
00613994763259 P980035 073
00613994763242 P980035 073
00613994763235 P980035 073
00613994295040 P980035 073
00613994223807 P980035 073
00613994222152 P980035 073
00613994222190 P980035 073
00613994222169 P980035 073
00613994763334 P980035 073
00613994222060 P980035 073
00613994222077 P980035 073
00613994222084 P980035 073
00613994222091 P980035 073
00613994222107 P980035 073
00613994222046 P980035 073
00613994222114 P980035 073
00613994222138 P980035 073
00885074042466 P980035 098
00643169050730 P980035 134
00643169050730 P980035 134
00613994713650 P980035 277
00613994713650 P980035 277
00643169441873 P980035 370
00643169474277 P980035 370
00643169441873 P980035 370
00643169474154 P980035 370
00643169474161 P980035 370
00643169474178 P980035 370
00643169474192 P980035 370
00643169474208 P980035 370
00643169474215 P980035 370
00643169474222 P980035 370
00643169474246 P980035 370
00643169474253 P980035 370
00643169474260 P980035 370
00643169474154 P980035 370
00643169474161 P980035 370
00643169474246 P980035 370
00643169474253 P980035 370
00643169474260 P980035 370
00643169474277 P980035 370
00643169493377 P980035 370
00643169493377 P980035 370
00643169474222 P980035 370
00643169474215 P980035 370
00643169474208 P980035 370
00643169474192 P980035 370
00643169474178 P980035 370
00643169402669 P980035 374
00643169402669 P980035 374
00763000059620 P980035 445
00763000059620 P980035 445
00763000059613 P980035 452
00763000059613 P980035 452
00643169708709 P980035 475
00643169708686 P980035 475
00643169708662 P980035 475
00643169708730 P980035 475
00643169708747 P980035 475
00643169708778 P980035 475
00643169708808 P980035 475
00643169708648 P980035 475
00643169709072 P980035 475
00643169709065 P980035 475
00643169709041 P980035 475
00643169708983 P980035 475
00643169708945 P980035 475
00643169708891 P980035 475
00643169708860 P980035 475
00643169708846 P980035 475
00643169708815 P980035 475
00643169708648 P980035 475
00643169708600 P980035 475
00643169708815 P980035 475
00643169708846 P980035 475
00643169708860 P980035 475
00643169708891 P980035 475
00643169708945 P980035 475
00643169708983 P980035 475
00643169709041 P980035 475
00643169709065 P980035 475
00643169708808 P980035 475
00643169708778 P980035 475
00643169709072 P980035 475
00643169708600 P980035 475
00643169708624 P980035 475
00643169708662 P980035 475
00643169708686 P980035 475
00643169708709 P980035 475
00643169708730 P980035 475
00643169708747 P980035 475
00643169708624 P980035 475
00643169871977 P980035 506
00643169871953 P980035 506
00643169871939 P980035 506
00643169871922 P980035 506
00643169634640 P980035 506
00643169634626 P980035 506
00643169634602 P980035 506
00643169634589 P980035 506
00643169871977 P980035 506
00643169871953 P980035 506
00643169871939 P980035 506
00643169871922 P980035 506
00643169634640 P980035 506
00643169634626 P980035 506
00643169634602 P980035 506
00643169634589 P980035 506
00763000002039 P980035 536
00763000316839 P980035 594
00763000316808 P980035 594
00763000316815 P980035 594
00763000316822 P980035 594
00763000316839 P980035 594
00763000316808 P980035 594
00763000316815 P980035 594
00763000316822 P980035 594
00763000316839 P980035 594
00763000316808 P980035 594
00763000316815 P980035 594
00763000316822 P980035 594
00763000316839 P980035 594
00763000316822 P980035 594
00763000316815 P980035 594
00763000316815 P980035 594
00763000316822 P980035 594
00763000316839 P980035 594
00763000316808 P980035 594
00763000316815 P980035 594
00763000316822 P980035 594
00763000316839 P980035 594
00763000316808 P980035 594
00763000316815 P980035 594
00763000316822 P980035 594
00763000316839 P980035 594
00763000316808 P980035 594
00763000316808 P980035 594
00763000316808 P980035 594
00763000316839 P980035 594
00763000316808 P980035 594
00763000316815 P980035 594
00763000316822 P980035 594
00763000316839 P980035 594
00763000316808 P980035 594
00763000316815 P980035 594
00763000316822 P980035 594
00763000316839 P980035 594
00763000316808 P980035 594
00763000316815 P980035 594
00763000316822 P980035 594
00763000316822 P980035 594
00763000316815 P980035 594
00763000316815 P980035 594
00763000316822 P980035 594
00763000316839 P980035 594
00763000316808 P980035 594
00763000316815 P980035 594
00763000316822 P980035 594
00763000316839 P980035 594
00763000316808 P980035 594
00763000316815 P980035 594
00763000316822 P980035 594
00763000316839 P980035 594
00763000316808 P980035 594
00763000316839 P980035 594

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