Approval for a new kit containing individually packaged lead anchoring sleeves. The kit will be marketed under the trade name model 5867 as anchoring sleeve kit and is intended for use with the medtronic implantable endocardial lead families listed.
| Device | ATTAIN OTW |
| Classification Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Applicant | MEDTRONIC Inc. |
| Date Received | 2009-03-17 |
| Decision Date | 2009-04-28 |
| PMA | P010015 |
| Supplement | S067 |
| Product Code | LWP |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDTRONIC Inc. 8200 Coral Sea Street Ne ms Mv S11 mounds View, MN 55112 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P010015 | | Original Filing |
| S513 |
2023-01-23 |
30-day Notice |
| S512 |
2023-01-09 |
30-day Notice |
| S511 |
2022-11-16 |
30-day Notice |
| S510 |
2022-11-16 |
30-day Notice |
| S509 |
2022-10-24 |
30-day Notice |
| S508 |
2022-10-18 |
30-day Notice |
| S507 |
2022-10-11 |
30-day Notice |
| S506 |
2022-09-13 |
30-day Notice |
| S505 |
2022-08-22 |
30-day Notice |
| S504 |
2022-08-02 |
30-day Notice |
| S503 |
2022-07-21 |
30-day Notice |
| S502 |
2022-07-13 |
30-day Notice |
| S501 |
2022-05-26 |
30-day Notice |
| S500 |
2022-05-20 |
30-day Notice |
| S499 |
2022-05-11 |
30-day Notice |
| S498 | | |
| S497 |
2022-04-27 |
30-day Notice |
| S496 |
2022-04-22 |
30-day Notice |
| S495 |
2022-04-14 |
30-day Notice |
| S494 |
2022-03-18 |
30-day Notice |
| S493 |
2022-03-10 |
30-day Notice |
| S492 |
2022-02-24 |
30-day Notice |
| S491 |
2022-01-18 |
30-day Notice |
| S490 |
2022-01-13 |
30-day Notice |
| S489 |
2022-01-13 |
30-day Notice |
| S488 |
2021-12-17 |
30-day Notice |
| S487 |
2021-11-30 |
30-day Notice |
| S486 |
2021-11-18 |
30-day Notice |
| S485 |
2021-11-17 |
30-day Notice |
| S484 |
2021-09-22 |
30-day Notice |
| S483 |
2021-09-13 |
30-day Notice |
| S482 |
2021-09-02 |
30-day Notice |
| S481 |
2021-08-09 |
30-day Notice |
| S480 |
2021-08-06 |
30-day Notice |
| S479 |
2021-07-30 |
30-day Notice |
| S478 |
2021-07-09 |
30-day Notice |
| S477 |
2021-06-15 |
30-day Notice |
| S476 |
2021-05-27 |
30-day Notice |
| S475 | | |
| S474 | | |
| S473 |
2021-04-20 |
30-day Notice |
| S472 |
2021-03-16 |
30-day Notice |
| S471 |
2021-03-08 |
30-day Notice |
| S470 | | |
| S469 | | |
| S468 |
2021-02-09 |
30-day Notice |
| S467 |
2021-02-08 |
30-day Notice |
| S466 |
2021-02-05 |
30-day Notice |
| S465 |
2021-01-12 |
30-day Notice |
| S464 | | |
| S463 | | |
| S462 |
2020-12-01 |
30-day Notice |
| S461 | | |
| S460 |
2020-11-20 |
30-day Notice |
| S459 |
2020-11-19 |
30-day Notice |
| S458 | | |
| S457 |
2020-11-17 |
30-day Notice |
| S456 | | |
| S455 |
2020-10-23 |
30-day Notice |
| S454 |
2020-10-20 |
30-day Notice |
| S453 |
2020-10-02 |
30-day Notice |
| S452 |
2020-09-23 |
30-day Notice |
| S451 |
2020-09-14 |
30-day Notice |
| S450 |
2020-09-04 |
30-day Notice |
| S449 |
2020-09-03 |
30-day Notice |
| S448 |
2020-08-19 |
30-day Notice |
| S447 | | |
| S446 |
2020-07-27 |
30-day Notice |
| S445 |
2020-07-14 |
30-day Notice |
| S444 |
2020-07-09 |
30-day Notice |
| S443 |
2020-07-09 |
30-day Notice |
| S442 |
2020-07-02 |
30-day Notice |
| S441 |
2020-06-26 |
30-day Notice |
| S440 |
2020-06-09 |
30-day Notice |
| S439 | | |
| S438 | | |
| S437 |
2020-05-21 |
30-day Notice |
| S436 |
2020-05-15 |
30-day Notice |
| S435 |
2020-04-08 |
30-day Notice |
| S434 |
2020-03-25 |
30-day Notice |
| S433 |
2020-03-16 |
30-day Notice |
| S432 |
2020-03-16 |
30-day Notice |
| S431 |
2020-03-12 |
30-day Notice |
| S430 | | |
| S429 |
2020-02-25 |
Real-time Process |
| S428 | | |
| S427 |
2020-02-20 |
30-day Notice |
| S426 |
2019-12-23 |
Real-time Process |
| S425 |
2019-12-11 |
30-day Notice |
| S424 |
2019-12-10 |
30-day Notice |
| S423 |
2019-11-25 |
30-day Notice |
| S422 |
2019-11-18 |
30-day Notice |
| S421 |
2019-11-12 |
30-day Notice |
| S420 |
2019-10-08 |
30-day Notice |
| S419 |
2019-09-16 |
30-day Notice |
| S418 |
2019-08-01 |
30-day Notice |
| S417 |
2019-07-29 |
30-day Notice |
| S416 |
2019-07-12 |
30-day Notice |
| S415 |
2019-07-01 |
30-day Notice |
| S414 |
2019-07-01 |
30-day Notice |
| S413 |
2019-06-20 |
30-day Notice |
| S412 |
2019-06-20 |
30-day Notice |
| S411 | | |
| S410 | | |
| S409 |
2019-06-10 |
30-day Notice |
| S408 |
2019-05-30 |
30-day Notice |
| S407 | | |
| S406 |
2019-05-06 |
30-day Notice |
| S405 |
2019-04-29 |
30-day Notice |
| S404 |
2019-04-23 |
30-day Notice |
| S403 |
2019-04-11 |
30-day Notice |
| S402 |
2019-04-03 |
30-day Notice |
| S401 |
2019-03-28 |
30-day Notice |
| S400 | | |
| S399 | | |
| S398 | | |
| S397 | | |
| S396 |
2019-03-05 |
30-day Notice |
| S395 |
2019-03-04 |
30-day Notice |
| S394 |
2019-02-28 |
30-day Notice |
| S393 |
2019-02-26 |
30-day Notice |
| S392 |
2019-02-25 |
30-day Notice |
| S391 |
2019-02-05 |
Real-time Process |
| S390 |
2019-01-23 |
30-day Notice |
| S389 |
2019-01-15 |
30-day Notice |
| S388 |
2018-12-10 |
30-day Notice |
| S387 |
2018-11-05 |
30-day Notice |
| S386 |
2018-11-01 |
30-day Notice |
| S385 | | |
| S384 |
2018-10-23 |
30-day Notice |
| S383 |
2018-10-18 |
30-day Notice |
| S382 |
2018-10-15 |
30-day Notice |
| S381 |
2018-10-09 |
30-day Notice |
| S380 |
2018-09-26 |
30-day Notice |
| S379 |
2018-08-29 |
30-day Notice |
| S378 |
2018-08-22 |
Real-time Process |
| S377 |
2018-08-08 |
30-day Notice |
| S376 |
2018-06-28 |
Normal 180 Day Track No User Fee |
| S375 |
2018-06-20 |
30-day Notice |
| S374 |
2018-06-01 |
30-day Notice |
| S373 |
2018-05-15 |
30-day Notice |
| S372 |
2018-05-14 |
30-day Notice |
| S371 |
2018-05-08 |
30-day Notice |
| S370 |
2018-04-23 |
30-day Notice |
| S369 |
2018-04-17 |
Real-time Process |
| S368 |
2018-04-13 |
Normal 180 Day Track |
| S367 |
2018-04-12 |
30-day Notice |
| S366 |
2018-04-12 |
30-day Notice |
| S365 | | |
| S364 |
2018-04-09 |
30-day Notice |
| S363 |
2018-03-30 |
30-day Notice |
| S362 |
2018-03-28 |
30-day Notice |
| S361 |
2018-03-22 |
30-day Notice |
| S360 |
2018-03-12 |
30-day Notice |
| S359 |
2018-03-12 |
30-day Notice |
| S358 |
2018-03-09 |
30-day Notice |
| S357 |
2018-03-07 |
Real-time Process |
| S356 |
2018-02-08 |
30-day Notice |
| S355 |
2018-02-01 |
Real-time Process |
| S354 |
2018-02-01 |
30-day Notice |
| S353 |
2018-01-29 |
Real-time Process |
| S352 |
2018-01-24 |
30-day Notice |
| S351 |
2017-12-22 |
30-day Notice |
| S350 | | |
| S349 |
2017-11-29 |
30-day Notice |
| S348 |
2017-11-20 |
30-day Notice |
| S347 |
2017-11-13 |
30-day Notice |
| S346 |
2017-11-07 |
30-day Notice |
| S345 |
2017-10-16 |
30-day Notice |
| S344 |
2017-09-28 |
30-day Notice |
| S343 |
2017-09-05 |
Real-time Process |
| S342 |
2017-08-07 |
30-day Notice |
| S341 |
2017-08-04 |
30-day Notice |
| S340 |
2017-07-21 |
Normal 180 Day Track |
| S339 |
2017-07-20 |
30-day Notice |
| S338 |
2017-07-14 |
Real-time Process |
| S337 |
2017-06-27 |
30-day Notice |
| S336 |
2017-06-23 |
30-day Notice |
| S335 |
2017-06-23 |
30-day Notice |
| S334 |
2017-06-08 |
30-day Notice |
| S333 |
2017-06-07 |
30-day Notice |
| S332 |
2017-05-18 |
30-day Notice |
| S331 |
2017-05-15 |
30-day Notice |
| S330 |
2017-05-12 |
30-day Notice |
| S329 |
2017-05-10 |
30-day Notice |
| S328 |
2017-05-10 |
30-day Notice |
| S327 |
2017-05-10 |
30-day Notice |
| S326 |
2017-04-04 |
30-day Notice |
| S325 |
2017-03-31 |
30-day Notice |
| S324 |
2017-03-29 |
30-day Notice |
| S323 |
2017-03-13 |
30-day Notice |
| S322 |
2017-03-08 |
30-day Notice |
| S321 |
2017-02-09 |
30-day Notice |
| S320 |
2017-01-17 |
30-day Notice |
| S319 |
2017-01-13 |
30-day Notice |
| S318 |
2016-12-15 |
Normal 180 Day Track |
| S317 |
2016-12-06 |
Normal 180 Day Track |
| S316 |
2016-11-28 |
30-day Notice |
| S315 |
2016-11-23 |
Real-time Process |
| S314 |
2016-11-16 |
Normal 180 Day Track |
| S313 |
2016-11-14 |
30-day Notice |
| S312 |
2016-10-05 |
30-day Notice |
| S311 |
2016-09-28 |
30-day Notice |
| S310 |
2016-09-26 |
30-day Notice |
| S309 |
2016-09-12 |
30-day Notice |
| S308 |
2016-09-08 |
Real-time Process |
| S307 |
2016-09-02 |
30-day Notice |
| S306 |
2016-07-22 |
30-day Notice |
| S305 |
2016-07-13 |
Real-time Process |
| S304 |
2016-06-24 |
Real-time Process |
| S303 |
2016-06-24 |
30-day Notice |
| S302 |
2016-06-22 |
30-day Notice |
| S301 |
2016-06-13 |
30-day Notice |
| S300 |
2016-04-26 |
30-day Notice |
| S299 |
2016-04-11 |
30-day Notice |
| S298 |
2016-03-31 |
30-day Notice |
| S297 |
2016-03-18 |
Real-time Process |
| S296 |
2016-03-17 |
30-day Notice |
| S295 |
2016-02-29 |
30-day Notice |
| S294 |
2016-02-25 |
30-day Notice |
| S293 |
2016-02-25 |
30-day Notice |
| S292 |
2016-02-05 |
30-day Notice |
| S291 |
2016-02-02 |
30-day Notice |
| S290 |
2015-12-28 |
30-day Notice |
| S289 |
2015-12-22 |
30-day Notice |
| S288 |
2015-12-18 |
Real-time Process |
| S287 |
2015-12-01 |
Normal 180 Day Track |
| S286 |
2015-10-22 |
Real-time Process |
| S285 |
2015-10-22 |
Real-time Process |
| S284 |
2015-10-19 |
30-day Notice |
| S283 |
2015-10-16 |
Real-time Process |
| S282 |
2015-09-30 |
30-day Notice |
| S281 | | |
| S280 |
2015-09-10 |
30-day Notice |
| S279 |
2015-08-28 |
Real-time Process |
| S278 |
2015-08-12 |
30-day Notice |
| S277 |
2015-08-11 |
30-day Notice |
| S276 |
2015-07-20 |
30-day Notice |
| S275 |
2015-07-02 |
Real-time Process |
| S274 |
2015-06-01 |
30-day Notice |
| S273 |
2015-05-22 |
30-day Notice |
| S272 |
2015-04-17 |
30-day Notice |
| S271 |
2015-04-14 |
Real-time Process |
| S270 |
2015-03-26 |
Real-time Process |
| S269 |
2015-03-23 |
30-day Notice |
| S268 |
2015-03-06 |
Real-time Process |
| S267 |
2015-02-09 |
30-day Notice |
| S266 |
2015-02-06 |
30-day Notice |
| S265 |
2015-02-05 |
30-day Notice |
| S264 |
2015-02-05 |
30-day Notice |
| S263 |
2015-02-04 |
30-day Notice |
| S262 |
2015-02-02 |
30-day Notice |
| S261 |
2015-02-02 |
30-day Notice |
| S260 |
2015-01-29 |
30-day Notice |
| S259 |
2015-01-23 |
30-day Notice |
| S258 |
2015-01-20 |
30-day Notice |
| S257 |
2015-01-12 |
30-day Notice |
| S256 |
2015-01-12 |
30-day Notice |
| S255 |
2014-12-22 |
Normal 180 Day Track |
| S254 |
2014-12-05 |
30-day Notice |
| S253 |
2014-10-02 |
30-day Notice |
| S252 |
2014-09-29 |
30-day Notice |
| S251 |
2014-09-19 |
30-day Notice |
| S250 |
2014-09-09 |
30-day Notice |
| S249 |
2014-08-27 |
30-day Notice |
| S248 |
2014-08-27 |
Real-time Process |
| S247 |
2014-08-08 |
30-day Notice |
| S246 |
2014-08-01 |
30-day Notice |
| S245 |
2014-07-24 |
30-day Notice |
| S244 |
2014-07-18 |
Normal 180 Day Track |
| S243 |
2014-07-15 |
30-day Notice |
| S242 |
2014-07-02 |
Real-time Process |
| S241 |
2014-06-13 |
30-day Notice |
| S240 |
2014-05-08 |
30-day Notice |
| S239 |
2014-05-01 |
30-day Notice |
| S238 |
2014-03-28 |
Real-time Process |
| S237 |
2014-03-28 |
Real-time Process |
| S236 |
2014-03-18 |
Real-time Process |
| S235 |
2014-03-07 |
30-day Notice |
| S234 |
2014-02-27 |
30-day Notice |
| S233 |
2014-01-31 |
30-day Notice |
| S232 |
2014-01-27 |
30-day Notice |
| S231 |
2013-12-24 |
30-day Notice |
| S230 |
2013-12-23 |
30-day Notice |
| S229 |
2013-12-19 |
Real-time Process |
| S228 |
2013-12-19 |
30-day Notice |
| S227 |
2013-12-18 |
Normal 180 Day Track |
| S226 |
2013-10-30 |
30-day Notice |
| S225 |
2013-10-24 |
30-day Notice |
| S224 |
2013-10-24 |
30-day Notice |
| S223 |
2013-10-17 |
30-day Notice |
| S222 |
2013-09-30 |
30-day Notice |
| S221 |
2013-09-24 |
30-day Notice |
| S220 |
2013-09-17 |
30-day Notice |
| S219 |
2013-09-17 |
30-day Notice |
| S218 |
2013-09-11 |
30-day Notice |
| S217 |
2013-09-06 |
Normal 180 Day Track No User Fee |
| S216 | | |
| S215 |
2013-08-23 |
Normal 180 Day Track |
| S214 |
2013-08-21 |
30-day Notice |
| S213 |
2013-08-20 |
30-day Notice |
| S212 |
2013-08-12 |
Real-time Process |
| S211 |
2013-07-26 |
30-day Notice |
| S210 |
2013-07-17 |
30-day Notice |
| S209 |
2013-07-11 |
Real-time Process |
| S208 |
2013-07-08 |
Normal 180 Day Track |
| S207 |
2013-07-02 |
30-day Notice |
| S206 |
2013-06-24 |
30-day Notice |
| S205 |
2013-05-29 |
Panel Track |
| S204 |
2013-05-21 |
30-day Notice |
| S203 |
2013-05-17 |
30-day Notice |
| S202 |
2013-05-17 |
Real-time Process |
| S201 |
2013-05-13 |
Real-time Process |
| S200 |
2013-04-30 |
30-day Notice |
| S199 |
2013-04-23 |
30-day Notice |
| S198 |
2013-04-18 |
Real-time Process |
| S197 |
2013-04-10 |
Normal 180 Day Track No User Fee |
| S196 |
2013-03-27 |
30-day Notice |
| S195 |
2013-03-22 |
30-day Notice |
| S194 |
2013-03-11 |
30-day Notice |
| S193 |
2013-03-05 |
30-day Notice |
| S192 |
2013-03-04 |
30-day Notice |
| S191 |
2013-03-04 |
30-day Notice |
| S190 |
2013-02-26 |
Normal 180 Day Track |
| S189 |
2013-02-21 |
30-day Notice |
| S188 |
2013-01-29 |
30-day Notice |
| S187 |
2013-01-22 |
30-day Notice |
| S186 |
2012-12-10 |
30-day Notice |
| S185 |
2012-11-29 |
30-day Notice |
| S184 |
2012-11-21 |
30-day Notice |
| S183 |
2012-11-15 |
30-day Notice |
| S182 |
2012-11-01 |
Real-time Process |
| S181 |
2012-10-05 |
30-day Notice |
| S180 |
2012-09-28 |
30-day Notice |
| S179 |
2012-09-21 |
30-day Notice |
| S178 |
2012-09-10 |
30-day Notice |
| S177 |
2012-09-07 |
30-day Notice |
| S176 |
2012-09-04 |
30-day Notice |
| S175 |
2012-08-24 |
Real-time Process |
| S174 |
2012-08-21 |
30-day Notice |
| S173 |
2012-08-08 |
30-day Notice |
| S172 |
2012-08-07 |
30-day Notice |
| S171 |
2012-08-03 |
30-day Notice |
| S170 |
2012-07-31 |
30-day Notice |
| S169 |
2012-07-25 |
30-day Notice |
| S168 |
2012-07-25 |
30-day Notice |
| S167 |
2012-07-23 |
30-day Notice |
| S166 |
2012-07-17 |
Normal 180 Day Track |
| S165 |
2012-06-29 |
30-day Notice |
| S164 |
2012-06-29 |
Real-time Process |
| S163 |
2012-05-17 |
30-day Notice |
| S162 |
2012-08-21 |
Normal 180 Day Track |
| S161 | | |
| S160 |
2012-04-04 |
Real-time Process |
| S159 |
2012-04-03 |
30-day Notice |
| S158 |
2012-03-07 |
30-day Notice |
| S157 |
2012-03-07 |
Normal 180 Day Track |
| S156 |
2012-03-05 |
30-day Notice |
| S155 |
2012-02-29 |
30-day Notice |
| S154 |
2012-02-13 |
30-day Notice |
| S153 | | |
| S152 |
2012-02-03 |
30-day Notice |
| S151 |
2011-12-20 |
30-day Notice |
| S150 |
2011-11-25 |
30-day Notice |
| S149 |
2011-11-23 |
30-day Notice |
| S148 |
2011-11-21 |
Normal 180 Day Track |
| S147 | | |
| S146 |
2011-11-14 |
30-day Notice |
| S145 |
2011-11-10 |
Real-time Process |
| S144 |
2011-10-26 |
30-day Notice |
| S143 |
2011-10-25 |
30-day Notice |
| S142 |
2011-10-24 |
135 Review Track For 30-day Notice |
| S141 |
2011-10-06 |
30-day Notice |
| S140 |
2011-09-22 |
30-day Notice |
| S139 |
2011-09-19 |
Real-time Process |
| S138 |
2011-09-16 |
30-day Notice |
| S137 |
2011-07-20 |
30-day Notice |
| S136 |
2011-07-18 |
30-day Notice |
| S135 |
2011-07-18 |
30-day Notice |
| S134 |
2011-07-08 |
30-day Notice |
| S133 |
2011-07-08 |
30-day Notice |
| S132 |
2011-07-06 |
30-day Notice |
| S131 |
2011-06-28 |
30-day Notice |
| S130 |
2011-06-08 |
30-day Notice |
| S129 |
2011-06-08 |
135 Review Track For 30-day Notice |
| S128 |
2011-06-07 |
30-day Notice |
| S127 |
2011-05-27 |
30-day Notice |
| S126 | | |
| S125 |
2011-05-19 |
Real-time Process |
| S124 |
2011-05-13 |
30-day Notice |
| S123 |
2011-05-10 |
30-day Notice |
| S122 |
2011-05-09 |
30-day Notice |
| S121 |
2011-04-26 |
30-day Notice |
| S120 |
2011-04-25 |
30-day Notice |
| S119 |
2011-04-25 |
Real-time Process |
| S118 |
2011-04-19 |
30-day Notice |
| S117 |
2011-04-15 |
30-day Notice |
| S116 |
2011-04-13 |
30-day Notice |
| S115 |
2011-04-11 |
30-day Notice |
| S114 |
2011-04-05 |
30-day Notice |
| S113 |
2011-04-04 |
30-day Notice |
| S112 |
2011-03-22 |
135 Review Track For 30-day Notice |
| S111 |
2011-03-18 |
135 Review Track For 30-day Notice |
| S110 | | |
| S109 |
2011-02-28 |
30-day Notice |
| S108 |
2011-01-25 |
30-day Notice |
| S107 |
2011-01-04 |
Normal 180 Day Track |
| S106 |
2010-12-09 |
30-day Notice |
| S105 |
2010-12-08 |
30-day Notice |
| S104 |
2010-11-12 |
30-day Notice |
| S103 |
2010-10-26 |
30-day Notice |
| S102 |
2010-10-14 |
30-day Notice |
| S101 |
2010-10-12 |
30-day Notice |
| S100 | | |
| S099 |
2010-08-13 |
30-day Notice |
| S098 |
2010-07-28 |
30-day Notice |
| S097 | | |
| S096 |
2010-07-15 |
30-day Notice |
| S095 |
2010-07-15 |
30-day Notice |
| S094 |
2010-07-15 |
30-day Notice |
| S093 |
2010-06-28 |
135 Review Track For 30-day Notice |
| S092 |
2010-06-15 |
Real-time Process |
| S091 | | |
| S090 |
2010-06-09 |
30-day Notice |
| S089 |
2010-06-02 |
30-day Notice |
| S088 |
2010-05-27 |
30-day Notice |
| S087 |
2010-05-20 |
Real-time Process |
| S086 |
2010-05-17 |
Normal 180 Day Track |
| S085 |
2010-05-03 |
30-day Notice |
| S084 |
2010-03-31 |
Normal 180 Day Track |
| S083 |
2010-03-29 |
30-day Notice |
| S082 |
2010-03-01 |
Real-time Process |
| S081 |
2010-02-19 |
135 Review Track For 30-day Notice |
| S080 |
2010-02-18 |
30-day Notice |
| S079 |
2010-02-18 |
30-day Notice |
| S078 |
2010-01-21 |
30-day Notice |
| S077 |
2010-01-19 |
30-day Notice |
| S076 |
2010-01-13 |
30-day Notice |
| S075 |
2009-12-08 |
30-day Notice |
| S074 |
2009-11-23 |
30-day Notice |
| S073 |
2009-10-08 |
Real-time Process |
| S072 |
2009-09-08 |
30-day Notice |
| S071 |
2009-07-01 |
135 Review Track For 30-day Notice |
| S070 |
2009-06-17 |
Real-time Process |
| S069 |
2009-06-11 |
30-day Notice |
| S068 |
2009-04-06 |
Real-time Process |
| S067 |
2009-03-17 |
Real-time Process |
| S066 |
2009-03-05 |
30-day Notice |
| S065 |
2009-03-02 |
Normal 180 Day Track |
| S064 |
2009-02-23 |
Real-time Process |
| S063 |
2009-02-18 |
135 Review Track For 30-day Notice |
| S062 |
2009-02-09 |
135 Review Track For 30-day Notice |
| S061 |
2009-02-05 |
30-day Notice |
| S060 |
2008-12-15 |
30-day Notice |
| S059 |
2008-12-11 |
30-day Notice |
| S058 |
2008-12-11 |
30-day Notice |
| S057 |
2008-11-20 |
30-day Notice |
| S056 |
2008-11-03 |
30-day Notice |
| S055 |
2008-10-17 |
Real-time Process |
| S054 | | |
| S053 |
2008-09-19 |
30-day Notice |
| S052 | | |
| S051 |
2008-08-11 |
30-day Notice |
| S050 |
2008-08-11 |
135 Review Track For 30-day Notice |
| S049 |
2008-08-04 |
135 Review Track For 30-day Notice |
| S048 |
2008-07-28 |
Normal 180 Day Track |
| S047 |
2008-07-25 |
135 Review Track For 30-day Notice |
| S046 |
2008-06-27 |
135 Review Track For 30-day Notice |
| S045 |
2008-06-18 |
30-day Notice |
| S044 |
2008-06-17 |
30-day Notice |
| S043 |
2008-04-14 |
30-day Notice |
| S042 |
2008-03-24 |
30-day Notice |
| S041 |
2008-03-21 |
30-day Notice |
| S040 | | |
| S039 |
2008-03-04 |
135 Review Track For 30-day Notice |
| S038 |
2008-02-26 |
30-day Notice |
| S037 |
2008-01-25 |
30-day Notice |
| S036 |
2007-11-19 |
30-day Notice |
| S035 |
2007-10-11 |
30-day Notice |
| S034 |
2007-09-28 |
Normal 180 Day Track |
| S033 |
2007-10-09 |
30-day Notice |
| S032 |
2007-09-17 |
135 Review Track For 30-day Notice |
| S031 |
2007-07-26 |
Real-time Process |
| S030 |
2007-06-27 |
Normal 180 Day Track No User Fee |
| S029 |
2007-06-11 |
Real-time Process |
| S028 |
2007-05-18 |
30-day Notice |
| S027 |
2007-03-09 |
Real-time Process |
| S026 |
2007-01-25 |
30-day Notice |
| S025 |
2006-10-17 |
30-day Notice |
| S024 |
2006-07-21 |
Real-time Process |
| S023 |
2006-05-10 |
135 Review Track For 30-day Notice |
| S022 |
2006-02-21 |
Real-time Process |
| S021 |
2006-02-14 |
Real-time Process |
| S020 |
2005-12-30 |
Normal 180 Day Track No User Fee |
| S019 |
2005-12-09 |
Normal 180 Day Track |
| S018 |
2005-12-08 |
Real-time Process |
| S017 | | |
| S016 |
2005-10-06 |
Normal 180 Day Track |
| S015 | | |
| S014 |
2004-08-23 |
Real-time Process |
| S013 |
2004-05-19 |
Normal 180 Day Track No User Fee |
| S012 |
2004-02-09 |
Normal 180 Day Track |
| S011 |
2003-08-22 |
Normal 180 Day Track No User Fee |
| S010 |
2003-04-08 |
Real-time Process |
| S009 |
2003-03-05 |
Normal 180 Day Track |
| S008 |
2002-12-03 |
Normal 180 Day Track |
| S007 |
2002-06-28 |
Normal 180 Day Track |
| S006 |
2002-02-27 |
Normal 180 Day Track |
| S005 |
2002-03-04 |
Normal 180 Day Track |
| S004 |
2001-12-03 |
Normal 180 Day Track |
| S003 |
2001-11-19 |
Normal 180 Day Track |
| S002 |
2001-11-05 |
Special (immediate Track) |
| S001 |
2001-09-24 |
30-day Notice |
NIH GUDID Devices