Approval for modifications to the device labeling to describe the care-hf clinical study. Medtronic also requests a reformatting of the indications statement and the addition of a clinical outcomes section to the device labeling which includes claims based on the primary endpoint and two secondary endpoints in the care-hf study. The medtronic insync iii model 8042 is indicated for nyha functional class iii and iv patients who remain symptomatic despite stable, optimal medical therapy (as defined in the clinical trials section), and have a left ventricular ejection fraction
| Device | INSYNC III BIVENTRICULAR PACING SYSTEM (MODEL 8041) |
| Classification Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Applicant | MEDTRONIC Inc. |
| Date Received | 2005-10-06 |
| Decision Date | 2006-03-07 |
| PMA | P010015 |
| Supplement | S016 |
| Product Code | LWP |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | Yes |
| 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