Approval for the insync iii model 8042 and insync iii model 9981 application software which is indicated as follows: the insync iii model 8042 device is indicated for the reduction of symptoms of moderate to severe heart failure (nyha class iii or iv), in those patients who remain symptomatic despite stable, optimal medical therapy (as defined in the clinical trials section), and have a left ventricular ejection fraction =130 ms. Rate adaptive pacing is provided for those patients developing a bradycardia indication who might benefit from increased pacing rates concurrent with increase in activity. Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of av synchrony.
| Device | INSYNC III MODEL 8042 AND INSYNC III MODEL 9981 APPLICATION SOFTWARE |
| Classification Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Applicant | MEDTRONIC Inc. |
| Date Received | 2002-03-04 |
| Decision Date | 2003-02-25 |
| PMA | P010015 |
| Supplement | S005 |
| Product Code | LWP |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| 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