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.
| Device | Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola |
| Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Applicant | MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP010015 Supplement NumberS494 Date Received03/18/2022 Decision Date03/24/2022 Product Code LWP Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-03-18 |
| Decision Date | 2022-03-24 |
| PMA | P010015 |
| Supplement | S494 |
| Product Code | LWP |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDTRONIC Inc. 8200 Coral Sea Street Ne ms Mv S11 mounds View, MN 55112 PMA NumberP010015 Supplement NumberS494 Date Received03/18/2022 Decision Date03/24/2022 Product Code LWP Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement to Reduce The Frequency Of The Monitoring Currently Used To Control The Residual Moisture Level Inside Hermetically Sealed Electronic Module Assemblies (EMAs) |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00885074200736 | P010015 | 003 |
| 00885074200743 | P010015 | 003 |
| 00885074200729 | P010015 | 003 |
| 00613994308658 | P010015 | 012 |
| 00885074113364 | P010015 | 012 |
| 00885074113371 | P010015 | 012 |
| 00613994753304 | P010015 | 084 |
| 00613994713667 | P010015 | 084 |
| 00643169351905 | P010015 | 227 |
| 00643169590571 | P010015 | 247 |
| 00643169590588 | P010015 | 247 |
| 00643169590595 | P010015 | 247 |
| 00643169735637 | P010015 | 317 |
| 00643169735644 | P010015 | 317 |
| 00643169735651 | P010015 | 317 |
| 00643169735668 | P010015 | 317 |
| 00643169735675 | P010015 | 317 |
| 00643169735682 | P010015 | 317 |
| 00643169891456 | P010015 | 338 |
| 00643169891449 | P010015 | 338 |
| 00643169891432 | P010015 | 338 |
| 00643169891425 | P010015 | 338 |
| 00643169891418 | P010015 | 338 |
| 00643169891401 | P010015 | 338 |
| 00763000002046 | P010015 | 399 |