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 NumberS506 Date Received09/13/2022 Decision Date09/21/2022 Product Code LWP Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-09-13 |
| Decision Date | 2022-09-21 |
| PMA | P010015 |
| Supplement | S506 |
| 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 NumberS506 Date Received09/13/2022 Decision Date09/21/2022 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 Replace The Water Wash Manufacturing Process With A Plasma Surface Treatment |
| 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 |