Claria MRI Quad CRT-D SureScan, Amplia MRI Quad CRT-D, Implantable Cardioverter Defibrillators with Cardiac Resynchroniz

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)

FDA Premarket Approval P010031 S563

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.

Pre-market Approval Supplement Details

Approval for the dual cathode left ventricular (lv) pacing feature for the claria mri quad crt-d surescan and the amplia mri quad crt-d surescan devices.

DeviceClaria MRI Quad CRT-D SureScan, Amplia MRI Quad CRT-D, Implantable Cardioverter Defibrillators with Cardiac Resynchroniz
Classification NameDefibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
Generic NameDefibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
Date Received2016-09-26
Decision Date2017-03-24
PMAP010031
SupplementS563
Product CodeNIK
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 Coral Sea Street N.e. mounds View, MN 55112
Post-Approval Study:Show Report Schedule and Study Progress

Supplemental Filings

Supplement NumberDateSupplement Type
P010031Original Filing
S813 2023-01-23 30-day Notice
S812 2023-01-19 30-day Notice
S811 2023-01-06 30-day Notice
S810
S809
S808 2022-11-16 30-day Notice
S807
S806 2022-10-24 30-day Notice
S805
S804 2022-10-18 30-day Notice
S803 2022-10-11 30-day Notice
S802 2022-09-16 30-day Notice
S801 2022-09-13 30-day Notice
S800 2022-08-23 30-day Notice
S799
S798 2022-08-09 30-day Notice
S797 2022-08-04 30-day Notice
S796
S795 2022-07-21 30-day Notice
S794
S793 2022-07-13 30-day Notice
S792 2022-06-27 30-day Notice
S791
S790 2022-05-20 30-day Notice
S789 2022-05-19 30-day Notice
S788
S787
S786 2022-05-11 30-day Notice
S785 2022-05-10 30-day Notice
S784
S783
S782 2022-04-27 30-day Notice
S781 2022-04-22 30-day Notice
S780 2022-04-14 30-day Notice
S779 2022-03-30 30-day Notice
S778
S777 2022-03-22 30-day Notice
S776 2022-03-18 30-day Notice
S775
S774 2022-03-10 30-day Notice
S773 2022-02-24 30-day Notice
S772 2022-01-28 30-day Notice
S771
S770 2022-01-18 30-day Notice
S769 2022-01-13 30-day Notice
S768
S767 2021-12-20 30-day Notice
S766 2021-11-30 30-day Notice
S765 2021-11-19 30-day Notice
S764 2021-11-18 30-day Notice
S763 2021-11-17 30-day Notice
S762
S761 2021-10-22 30-day Notice
S760 2021-10-21 30-day Notice
S759 2021-10-01 30-day Notice
S758 2021-09-22 30-day Notice
S757 2021-09-13 30-day Notice
S756 2021-09-02 30-day Notice
S755 2021-08-23 30-day Notice
S754 2021-08-09 30-day Notice
S753 2021-07-30 30-day Notice
S752 2021-07-15 30-day Notice
S751 2021-07-09 30-day Notice
S750
S749 2021-06-23 30-day Notice
S748 2021-05-27 30-day Notice
S747
S746
S745 2021-04-20 30-day Notice
S744 2021-04-08 30-day Notice
S743 2021-04-06 30-day Notice
S742
S741 2021-03-16 30-day Notice
S740 2021-03-11 30-day Notice
S739 2021-03-09 30-day Notice
S738 2021-03-08 30-day Notice
S737
S736
S735 2021-02-25 30-day Notice
S734
S733
S732 2021-02-08 30-day Notice
S731 2021-02-05 30-day Notice
S730
S729 2021-01-08 30-day Notice
S728
S727 2020-11-25 30-day Notice
S726 2020-11-24 30-day Notice
S725 2020-11-19 30-day Notice
S724
S723 2020-11-18 30-day Notice
S722 2020-11-06 30-day Notice
S721 2020-10-23 30-day Notice
S720
S719 2020-10-20 30-day Notice
S718 2020-10-14 30-day Notice
S717 2020-09-23 30-day Notice
S716 2020-09-04 30-day Notice
S715 2020-08-28 30-day Notice
S714 2020-08-19 30-day Notice
S713
S712 2020-07-27 30-day Notice
S711
S710 2020-07-14 30-day Notice
S709 2020-07-09 30-day Notice
S708
S707 2020-06-26 30-day Notice
S706 2020-06-26 30-day Notice
S705 2020-06-18 30-day Notice
S704 2020-06-09 30-day Notice
S703
S702 2020-05-15 30-day Notice
S701 2020-04-29 30-day Notice
S700 2020-04-08 30-day Notice
S699 2020-03-25 30-day Notice
S698 2020-03-25 30-day Notice
S697 2020-03-16 30-day Notice
S696 2020-03-16 30-day Notice
S695 2020-03-12 30-day Notice
S694 2020-03-10 30-day Notice
S693 2020-03-09 30-day Notice
S692
S691
S690 2020-02-20 30-day Notice
S689 2019-12-23 Real-time Process
S688 2019-12-20 30-day Notice
S687 2019-12-11 30-day Notice
S686 2019-12-10 30-day Notice
S685 2019-11-18 30-day Notice
S684
S683
S682 2019-10-08 30-day Notice
S681 2019-09-16 30-day Notice
S680 2019-09-13 30-day Notice
S679 2019-08-26 30-day Notice
S678 2019-08-01 30-day Notice
S677 2019-07-12 30-day Notice
S676 2019-07-01 30-day Notice
S675 2019-07-01 30-day Notice
S674
S673 2019-06-20 30-day Notice
S672
S671 2019-06-11 30-day Notice
S670 2019-06-10 30-day Notice
S669 2019-05-30 30-day Notice
S668 2019-05-20 30-day Notice
S667 2019-05-02 Normal 180 Day Track No User Fee
S666 2019-04-23 30-day Notice
S665 2019-04-11 30-day Notice
S664 2019-04-03 30-day Notice
S663 2019-03-28 30-day Notice
S662
S661
S660 2019-03-04 30-day Notice
S659 2019-02-25 30-day Notice
S658 2019-01-30 Normal 180 Day Track No User Fee
S657 2018-11-21 Normal 180 Day Track No User Fee
S656 2018-11-05 30-day Notice
S655 2018-11-01 30-day Notice
S654 2018-10-26 Normal 180 Day Track
S653 2018-10-23 30-day Notice
S652 2018-10-18 30-day Notice
S651 2018-10-18 30-day Notice
S650 2018-10-17 Real-time Process
S649 2018-10-15 30-day Notice
S648 2018-10-09 30-day Notice
S647 2018-10-09 30-day Notice
S646 2018-09-26 30-day Notice
S645 2018-09-07 Real-time Process
S644 2018-08-22 Real-time Process
S643 2018-08-17 30-day Notice
S642 2018-08-08 30-day Notice
S641 2018-07-23 30-day Notice
S640 2018-06-28 Normal 180 Day Track No User Fee
S639 2018-06-25 Real-time Process
S638 2018-06-19 30-day Notice
S637 2018-06-07 Real-time Process
S636 2018-06-07 Real-time Process
S635 2018-06-01 30-day Notice
S634 2018-05-29 30-day Notice
S633 2018-05-29 30-day Notice
S632 2018-05-16 30-day Notice
S631 2018-05-15 30-day Notice
S630 2018-04-24 30-day Notice
S629 2018-04-23 30-day Notice
S628 2018-04-17 Real-time Process
S627 2018-04-13 30-day Notice
S626 2018-04-13 Normal 180 Day Track
S625 2018-04-12 30-day Notice
S624 2018-04-09 30-day Notice
S623 2018-04-06 30-day Notice
S622 2018-03-30 30-day Notice
S621 2018-03-12 30-day Notice
S620 2018-03-12 30-day Notice
S619 2018-03-09 30-day Notice
S618 2018-02-01 Real-time Process
S617 2018-01-24 30-day Notice
S616 2018-01-18 30-day Notice
S615 2017-12-12 30-day Notice
S614 2017-12-12 30-day Notice
S613 2017-12-01 30-day Notice
S612 2017-11-29 30-day Notice
S611 2017-11-20 30-day Notice
S610 2017-11-16 Real-time Process
S609 2017-11-15 30-day Notice
S608 2017-11-13 30-day Notice
S607 2017-11-07 30-day Notice
S606 2017-10-02 30-day Notice
S605 2017-09-20 30-day Notice
S604 2017-09-20 30-day Notice
S603 2017-09-20 30-day Notice
S602 2017-09-07 30-day Notice
S601 2017-09-05 Real-time Process
S600 2017-09-01 Real-time Process
S599 2017-08-07 Real-time Process
S598 2017-06-23 30-day Notice
S597 2017-06-07 30-day Notice
S596 2017-06-07 30-day Notice
S595 2017-05-24 30-day Notice
S594 2017-05-18 30-day Notice
S593 2017-05-12 30-day Notice
S592 2017-04-19 30-day Notice
S591
S590 2017-04-03 30-day Notice
S589 2017-03-31 30-day Notice
S588 2017-03-29 30-day Notice
S587 2017-03-13 30-day Notice
S586 2017-03-08 30-day Notice
S585 2017-02-17 30-day Notice
S584 2017-02-14 Real-time Process
S583 2017-02-09 Real-time Process
S582 2017-02-09 30-day Notice
S581 2017-02-08 30-day Notice
S580 2017-02-03 30-day Notice
S579 2017-01-31 Normal 180 Day Track
S578 2017-01-25 30-day Notice
S577 2017-01-25 Real-time Process
S576 2017-01-13 30-day Notice
S575 2016-12-15 Normal 180 Day Track
S574 2016-11-28 30-day Notice
S573 2016-11-23 Real-time Process
S572 2016-11-16 Normal 180 Day Track
S571 2016-11-14 30-day Notice
S570 2016-11-10 Real-time Process
S569 2016-11-02 Normal 180 Day Track
S568 2016-10-28 30-day Notice
S567 2016-10-14 Real-time Process
S566 2016-10-07 30-day Notice
S565 2016-09-28 30-day Notice
S564 2016-09-27 30-day Notice
S563 2016-09-26 Normal 180 Day Track
S562 2016-09-26 30-day Notice
S561 2016-09-15 30-day Notice
S560 2016-09-08 Real-time Process
S559 2016-08-19 30-day Notice
S558 2016-07-22 30-day Notice
S557 2016-07-13 Real-time Process
S556 2016-07-01 30-day Notice
S555 2016-06-24 30-day Notice
S554 2016-06-24 Real-time Process
S553 2016-06-01 Normal 180 Day Track
S552 2016-05-17 30-day Notice
S551 2016-05-11 30-day Notice
S550 2016-05-03 Normal 180 Day Track
S549 2016-05-03 30-day Notice
S548 2016-04-29 30-day Notice
S547 2016-04-28 Real-time Process
S546 2016-04-14 Real-time Process
S545 2016-04-11 30-day Notice
S544 2016-03-31 30-day Notice
S543 2016-03-18 Real-time Process
S542 2016-03-18 Real-time Process
S541 2016-03-17 30-day Notice
S540 2016-03-11 Normal 180 Day Track
S539 2016-03-04 30-day Notice
S538 2016-03-01 Normal 180 Day Track
S537 2016-02-29 30-day Notice
S536 2016-02-25 30-day Notice
S535 2016-02-22 30-day Notice
S534 2016-02-17 30-day Notice
S533 2016-02-11 Real-time Process
S532 2016-02-08 30-day Notice
S531 2016-02-05 30-day Notice
S530 2016-02-04 Real-time Process
S529 2016-02-03 30-day Notice
S528 2016-02-02 30-day Notice
S527 2016-02-02 30-day Notice
S526 2016-01-11 Real-time Process
S525 2015-12-28 30-day Notice
S524 2015-12-18 Real-time Process
S523 2015-12-01 Normal 180 Day Track
S522 2015-11-16 Normal 180 Day Track
S521 2015-10-22 Real-time Process
S520 2015-10-22 Real-time Process
S519 2015-10-22 Real-time Process
S518 2015-10-19 30-day Notice
S517 2015-10-16 Real-time Process
S516 2015-10-09 30-day Notice
S515 2015-09-30 30-day Notice
S514 2015-09-30 30-day Notice
S513 2015-09-24 Normal 180 Day Track
S512
S511 2015-09-04 Normal 180 Day Track
S510 2015-08-28 Real-time Process
S509 2015-08-11 30-day Notice
S508
S507 2015-07-24 30-day Notice
S506 2015-07-21 30-day Notice
S505 2015-07-02 Real-time Process
S504 2015-07-01 30-day Notice
S503
S502 2015-06-01 30-day Notice
S501 2015-04-17 30-day Notice
S500 2015-04-14 Real-time Process
S499 2015-03-06 Real-time Process
S498 2015-03-03 30-day Notice
S497 2015-02-18 30-day Notice
S496 2015-02-18 30-day Notice
S495 2015-02-18 30-day Notice
S494 2015-02-06 30-day Notice
S493 2015-02-06 30-day Notice
S492 2015-02-05 30-day Notice
S491 2015-02-05 30-day Notice
S490 2015-02-04 30-day Notice
S489 2015-02-02 30-day Notice
S488 2015-02-02 30-day Notice
S487 2015-01-29 30-day Notice
S486 2015-01-28 30-day Notice
S485 2015-01-23 Normal 180 Day Track
S484 2015-01-23 30-day Notice
S483 2015-01-22 30-day Notice
S482 2015-01-20 30-day Notice
S481 2015-01-20 30-day Notice
S480 2015-01-12 30-day Notice
S479 2014-12-24 30-day Notice
S478 2014-12-22 Normal 180 Day Track
S477 2014-12-18 Real-time Process
S476 2014-12-08 30-day Notice
S475 2014-12-05 30-day Notice
S474 2014-11-24 30-day Notice
S473 2014-11-07 30-day Notice
S472 2014-10-14 30-day Notice
S471 2014-10-02 30-day Notice
S470 2014-09-25 30-day Notice
S469 2014-09-19 30-day Notice
S468 2014-09-15 30-day Notice
S467 2014-09-03 Real-time Process
S466 2014-09-02 Normal 180 Day Track
S465 2014-08-27 30-day Notice
S464 2014-08-27 Real-time Process
S463 2014-08-22 30-day Notice
S462 2014-08-18 30-day Notice
S461 2014-08-15 30-day Notice
S460 2014-08-05 30-day Notice
S459 2014-08-01 30-day Notice
S458 2014-07-31 30-day Notice
S457 2014-07-24 30-day Notice
S456 2014-07-23 30-day Notice
S455 2014-07-18 Normal 180 Day Track
S454 2014-07-15 30-day Notice
S453 2014-07-15 30-day Notice
S452 2014-07-03 30-day Notice
S451 2014-07-02 Real-time Process
S450 2014-06-20 30-day Notice
S449 2014-06-18 30-day Notice
S448 2014-06-13 30-day Notice
S447 2014-05-30 30-day Notice
S446 2014-05-23 30-day Notice
S445 2014-05-08 30-day Notice
S444 2014-04-30 30-day Notice
S443 2014-04-18 Real-time Process
S442 2014-04-11 Normal 180 Day Track
S441 2014-04-01 30-day Notice
S440 2014-03-28 Real-time Process
S439 2014-03-28 Real-time Process
S438 2014-03-28 Real-time Process
S437 2014-03-27 30-day Notice
S436 2014-03-20 30-day Notice
S435 2014-03-19 Real-time Process
S434 2014-03-18 30-day Notice
S433 2014-03-18 Real-time Process
S432 2014-03-13 30-day Notice
S431 2014-03-07 30-day Notice
S430 2014-02-27 30-day Notice
S429 2014-02-18 30-day Notice
S428 2014-02-18 30-day Notice
S427 2014-02-18 30-day Notice
S426 2014-02-14 30-day Notice
S425 2014-02-14 Real-time Process
S424 2014-01-30 30-day Notice
S423 2014-01-30 30-day Notice
S422 2014-01-29 30-day Notice
S421 2014-01-27 30-day Notice
S420 2014-01-24 135 Review Track For 30-day Notice
S419 2014-01-22 30-day Notice
S418 2014-01-10 30-day Notice
S417 2013-12-26 Real-time Process
S416 2013-12-19 Real-time Process
S415 2013-12-19 30-day Notice
S414 2013-12-18 Normal 180 Day Track
S413 2013-12-16 Normal 180 Day Track
S412 2013-11-27 30-day Notice
S411 2013-11-20 30-day Notice
S410 2013-11-19 30-day Notice
S409 2013-11-18 30-day Notice
S408 2013-11-18 30-day Notice
S407 2013-11-18 30-day Notice
S406 2013-10-24 30-day Notice
S405
S404 2013-09-27 135 Review Track For 30-day Notice
S403 2013-09-24 30-day Notice
S402 2013-09-13 Normal 180 Day Track No User Fee
S401 2013-09-11 30-day Notice
S400 2013-09-10 30-day Notice
S399 2013-09-06 30-day Notice
S398 2013-09-04 Real-time Process
S397 2013-08-23 Normal 180 Day Track
S396 2013-08-15 Normal 180 Day Track
S395
S394 2013-08-12 Real-time Process
S393 2013-08-09 30-day Notice
S392 2013-08-06 Real-time Process
S391 2013-07-26 30-day Notice
S390 2013-07-26 30-day Notice
S389 2013-07-17 30-day Notice
S388 2013-07-16 30-day Notice
S387 2013-07-10 Normal 180 Day Track
S386 2013-07-08 Normal 180 Day Track
S385 2013-07-01 30-day Notice
S384 2013-06-26 30-day Notice
S383 2013-06-07 30-day Notice
S382 2013-06-03 30-day Notice
S381 2013-05-29 Panel Track
S380 2013-05-29 30-day Notice
S379 2013-05-21 30-day Notice
S378 2013-05-17 30-day Notice
S377 2013-05-17 Real-time Process
S376 2013-05-13 Real-time Process
S375 2013-04-26 30-day Notice
S374 2013-04-23 30-day Notice
S373 2013-04-18 Real-time Process
S372 2013-04-10 Normal 180 Day Track No User Fee
S371 2013-04-09 30-day Notice
S370 2013-04-08 30-day Notice
S369 2013-04-01 30-day Notice
S368 2013-03-20 30-day Notice
S367 2013-03-11 30-day Notice
S366 2013-03-07 30-day Notice
S365 2013-03-05 30-day Notice
S364 2013-03-04 30-day Notice
S363 2013-02-26 Normal 180 Day Track
S362 2013-02-21 30-day Notice
S361 2013-02-21 Normal 180 Day Track No User Fee
S360 2013-02-20 30-day Notice
S359 2013-02-15 30-day Notice
S358 2013-02-08 30-day Notice
S357 2013-02-07 30-day Notice
S356 2013-02-07 30-day Notice
S355 2013-02-06 30-day Notice
S354 2013-02-06 30-day Notice
S353 2013-02-06 30-day Notice
S352 2013-02-05 30-day Notice
S351 2013-02-05 30-day Notice
S350
S349 2013-02-04 30-day Notice
S348 2013-02-04 30-day Notice
S347 2013-02-01 30-day Notice
S346 2013-02-01 30-day Notice
S345 2013-01-22 30-day Notice
S344 2012-12-19 Normal 180 Day Track
S343 2012-12-10 30-day Notice
S342 2012-11-21 30-day Notice
S341 2012-11-16 30-day Notice
S340 2012-11-01 Real-time Process
S339 2012-10-19 30-day Notice
S338 2012-10-09 30-day Notice
S337
S336 2012-09-27 Real-time Process
S335 2012-09-10 30-day Notice
S334 2012-08-24 Real-time Process
S333 2012-08-24 30-day Notice
S332 2012-08-23 30-day Notice
S331 2012-08-21 30-day Notice
S330 2012-08-08 30-day Notice
S329 2012-08-07 Normal 180 Day Track
S328 2012-08-07 30-day Notice
S327 2012-08-06 30-day Notice
S326 2012-08-03 30-day Notice
S325 2012-07-31 30-day Notice
S324 2012-07-25 30-day Notice
S323 2012-07-25 30-day Notice
S322 2012-07-23 30-day Notice
S321 2012-07-19 30-day Notice
S320 2012-07-18 30-day Notice
S319 2012-07-17 Normal 180 Day Track
S318 2012-07-05 Normal 180 Day Track
S317 2012-07-03 30-day Notice
S316 2012-06-29 Real-time Process
S315 2012-06-19 Normal 180 Day Track No User Fee
S314 2012-06-11 Normal 180 Day Track
S313 2012-06-08 135 Review Track For 30-day Notice
S312
S311 2012-05-31 30-day Notice
S310 2012-08-21 Normal 180 Day Track
S309 2012-05-21 30-day Notice
S308 2012-05-17 30-day Notice
S307 2012-05-17 30-day Notice
S306 2012-05-11 30-day Notice
S305 2012-05-02 Normal 180 Day Track No User Fee
S304 2012-05-01 Normal 180 Day Track No User Fee
S303 2012-04-25 30-day Notice
S302
S301 2012-04-11 30-day Notice
S300 2012-04-06 30-day Notice
S299 2012-04-04 Real-time Process
S298 2012-03-28 30-day Notice
S297 2012-03-07 30-day Notice
S296 2012-03-07 Normal 180 Day Track
S295 2012-03-05 30-day Notice
S294 2012-02-29 30-day Notice
S293 2012-02-27 Real-time Process
S292 2012-02-22 Real-time Process
S291 2012-02-13 30-day Notice
S290 2012-02-09 30-day Notice
S289 2012-02-09 30-day Notice
S288 2012-02-07 30-day Notice
S287 2012-02-03 30-day Notice
S286 2011-12-20 30-day Notice
S285 2011-11-25 30-day Notice
S284 2011-11-21 Normal 180 Day Track
S283 2011-11-17 30-day Notice
S282
S281 2011-11-14 30-day Notice
S280 2011-11-10 Real-time Process
S279 2011-11-04 30-day Notice
S278 2011-10-06 30-day Notice
S277 2011-09-19 Real-time Process
S276 2011-09-16 30-day Notice
S275 2011-09-13 Real-time Process
S274
S273 2011-08-30 30-day Notice
S272 2011-07-20 30-day Notice
S271 2011-07-20 30-day Notice
S270 2011-07-18 30-day Notice
S269 2011-07-18 30-day Notice
S268 2011-07-18 135 Review Track For 30-day Notice
S267 2011-07-15 30-day Notice
S266 2011-07-13 30-day Notice
S265 2011-07-08 30-day Notice
S264 2011-07-06 30-day Notice
S263 2011-06-30 30-day Notice
S262 2011-06-28 30-day Notice
S261 2011-06-15 30-day Notice
S260 2011-06-10 30-day Notice
S259 2011-06-09 135 Review Track For 30-day Notice
S258 2011-06-08 30-day Notice
S257 2011-06-07 30-day Notice
S256 2011-05-13 30-day Notice
S255 2011-05-10 30-day Notice
S254 2011-05-09 30-day Notice
S253 2011-04-29 30-day Notice
S252 2011-04-28 Normal 180 Day Track
S251 2011-04-26 30-day Notice
S250 2011-04-25 30-day Notice
S249 2011-04-25 Real-time Process
S248 2011-04-15 30-day Notice
S247 2011-04-13 30-day Notice
S246 2011-04-11 30-day Notice
S245 2011-04-06 30-day Notice
S244 2011-04-05 30-day Notice
S243 2011-04-04 30-day Notice
S242 2011-03-22 135 Review Track For 30-day Notice
S241
S240
S239 2011-03-02 30-day Notice
S238 2011-02-18 30-day Notice
S237 2011-02-16 30-day Notice
S236 2011-02-15 30-day Notice
S235 2011-02-01 30-day Notice
S234 2011-01-31 30-day Notice
S233 2011-01-25 30-day Notice
S232 2011-01-24 Panel Track
S231 2011-01-18 30-day Notice
S230 2011-01-18 30-day Notice
S229 2011-01-05 30-day Notice
S228 2011-01-04 Normal 180 Day Track
S227 2010-12-20 30-day Notice
S226 2010-12-20 30-day Notice
S225 2010-12-14 30-day Notice
S224 2010-12-09 30-day Notice
S223 2010-12-08 30-day Notice
S222 2010-12-07 Real-time Process
S221 2010-12-07 30-day Notice
S220 2010-11-12 30-day Notice
S219 2010-10-26 30-day Notice
S218 2010-10-15 30-day Notice
S217 2010-10-12 30-day Notice
S216 2010-09-16 30-day Notice
S215 2010-09-14 30-day Notice
S214 2010-07-28 30-day Notice
S213 2010-07-26 30-day Notice
S212 2010-07-23 30-day Notice
S211 2010-07-20 Real-time Process
S210 2010-07-15 30-day Notice
S209 2010-07-15 30-day Notice
S208 2010-07-08 Real-time Process
S207 2010-06-30 30-day Notice
S206 2010-06-28 135 Review Track For 30-day Notice
S205 2010-06-24 30-day Notice
S204 2010-06-23 30-day Notice
S203 2010-06-18 30-day Notice
S202 2010-06-08 30-day Notice
S201 2010-06-02 30-day Notice
S200
S199 2010-05-20 Real-time Process
S198 2010-05-17 Normal 180 Day Track
S197 2010-05-07 30-day Notice
S196 2010-05-03 30-day Notice
S195 2010-04-12 30-day Notice
S194 2010-03-31 30-day Notice
S193 2010-03-31 Real-time Process
S192 2010-03-29 30-day Notice
S191 2010-03-01 Real-time Process
S190
S189 2010-02-19 135 Review Track For 30-day Notice
S188 2010-02-18 30-day Notice
S187 2010-02-18 30-day Notice
S186 2010-02-12 30-day Notice
S185 2010-02-05 30-day Notice
S184 2010-02-04 30-day Notice
S183 2010-01-25 30-day Notice
S182 2010-01-21 30-day Notice
S181 2010-01-19 30-day Notice
S180 2010-01-13 30-day Notice
S179 2010-01-08 30-day Notice
S178 2009-12-23 Normal 180 Day Track
S177 2009-12-08 30-day Notice
S176 2009-12-04 Normal 180 Day Track
S175 2009-12-02 30-day Notice
S174 2009-12-02 30-day Notice
S173 2009-11-27 30-day Notice
S172 2009-11-23 30-day Notice
S171 2009-10-22 Normal 180 Day Track
S170 2009-10-08 Real-time Process
S169 2009-10-08 Normal 180 Day Track No User Fee
S168 2009-10-02 30-day Notice
S167 2009-09-21 135 Review Track For 30-day Notice
S166
S165 2009-09-08 30-day Notice
S164 2009-09-08 30-day Notice
S163 2009-08-21 30-day Notice
S162 2009-08-05 30-day Notice
S161
S160 2009-07-22 30-day Notice
S159 2009-06-30 30-day Notice
S158 2009-06-17 Real-time Process
S157 2009-06-11 30-day Notice
S156 2009-06-02 135 Review Track For 30-day Notice
S155 2009-05-18 30-day Notice
S154 2009-04-10 30-day Notice
S153 2009-03-30 30-day Notice
S152 2009-03-25 30-day Notice
S151 2009-03-16 30-day Notice
S150 2009-03-06 Normal 180 Day Track
S149 2009-03-06 30-day Notice
S148 2009-03-04 30-day Notice
S147 2009-03-02 Normal 180 Day Track
S146 2009-02-23 Real-time Process
S145 2009-02-18 135 Review Track For 30-day Notice
S144 2009-02-13 135 Review Track For 30-day Notice
S143 2009-02-09 135 Review Track For 30-day Notice
S142 2009-01-26 30-day Notice
S141 2009-01-16 Real-time Process
S140 2009-01-13 30-day Notice
S139 2008-12-11 30-day Notice
S138 2008-12-11 30-day Notice
S137 2008-12-03 135 Review Track For 30-day Notice
S136 2008-11-26 30-day Notice
S135 2008-11-26 135 Review Track For 30-day Notice
S134 2008-11-20 30-day Notice
S133 2008-11-17 135 Review Track For 30-day Notice
S132 2008-11-04 Normal 180 Day Track
S131 2008-10-22 Normal 180 Day Track
S130 2008-10-17 Real-time Process
S129 2008-10-14 30-day Notice
S128 2008-10-06 30-day Notice
S127 2008-10-02 135 Review Track For 30-day Notice
S126 2008-09-26 Real-time Process
S125 2008-09-24 Real-time Process
S124 2008-09-22 30-day Notice
S123 2008-09-19 30-day Notice
S122 2008-09-19 30-day Notice
S121 2008-09-17 30-day Notice
S120 2008-09-08 30-day Notice
S119
S118 2008-08-18 30-day Notice
S117 2008-08-11 30-day Notice
S116 2008-08-05 30-day Notice
S115 2008-08-04 135 Review Track For 30-day Notice
S114 2008-07-28 Normal 180 Day Track
S113 2008-07-25 135 Review Track For 30-day Notice
S112 2008-07-23 30-day Notice
S111 2008-07-17 30-day Notice
S110 2008-07-16 30-day Notice
S109 2008-07-02 135 Review Track For 30-day Notice
S108 2008-07-02 30-day Notice
S107 2008-06-27 135 Review Track For 30-day Notice
S106 2008-06-12 30-day Notice
S105 2008-06-10 30-day Notice
S104 2008-06-09 Normal 180 Day Track
S103 2008-06-09 Real-time Process
S102 2008-06-03 30-day Notice
S101 2008-06-02 Normal 180 Day Track No User Fee
S100 2008-05-23 30-day Notice
S099 2008-05-21 Real-time Process
S098 2008-04-14 30-day Notice
S097 2008-04-14 30-day Notice
S096 2008-04-10 Real-time Process
S095 2008-03-21 30-day Notice
S094
S093 2008-03-04 30-day Notice
S092 2008-01-25 30-day Notice
S091 2008-01-14 135 Review Track For 30-day Notice
S090 2007-12-26 135 Review Track For 30-day Notice
S089 2007-12-17 30-day Notice
S088 2007-12-10 Real-time Process
S087 2007-11-19 30-day Notice
S086 2007-11-19 30-day Notice
S085 2007-11-16 Real-time Process
S084 2007-10-31 Normal 180 Day Track
S083 2007-10-18 30-day Notice
S082 2007-10-11 30-day Notice
S081 2007-09-28 Normal 180 Day Track
S080 2007-09-24 Normal 180 Day Track No User Fee
S079 2007-09-17 135 Review Track For 30-day Notice
S078 2007-08-23 Special (immediate Track)
S077 2007-08-22 30-day Notice
S076 2007-08-14 Real-time Process
S075 2007-08-13 30-day Notice
S074 2007-08-13 30-day Notice
S073 2007-07-12 Normal 180 Day Track No User Fee
S072 2007-07-12 30-day Notice
S071 2007-05-31 30-day Notice
S070 2007-05-16 Real-time Process
S069 2007-04-24 Real-time Process
S068 2007-05-21 Real-time Process
S067 2007-04-02 Real-time Process
S066 2007-03-09 Real-time Process
S065 2007-03-12 135 Review Track For 30-day Notice
S064 2007-02-28 Real-time Process
S063 2007-02-12 Real-time Process
S062 2007-01-16 Real-time Process
S061 2006-12-20 Real-time Process
S060 2006-12-14 30-day Notice
S059 2006-12-01 Normal 180 Day Track No User Fee
S058 2006-11-28 Real-time Process
S057 2006-11-07 Normal 180 Day Track
S056 2006-10-30 Real-time Process
S055 2006-10-30 Normal 180 Day Track No User Fee
S054 2006-10-17 30-day Notice
S053 2006-10-10 Real-time Process
S052 2006-10-03 Special (immediate Track)
S051 2006-08-24 Real-time Process
S050 2006-08-21 Normal 180 Day Track No User Fee
S049 2006-08-03 135 Review Track For 30-day Notice
S048 2006-07-28 Real-time Process
S047 2006-07-20 30-day Notice
S046 2006-07-19 30-day Notice
S045 2006-07-17 30-day Notice
S044 2006-06-19 Real-time Process
S043 2006-06-05 Real-time Process
S042 2006-06-02 Real-time Process
S041 2006-05-10 135 Review Track For 30-day Notice
S040 2006-04-11 Real-time Process
S039 2006-04-10 Real-time Process
S038 2006-02-21 Real-time Process
S037 2006-02-14 Real-time Process
S036 2006-02-09 30-day Notice
S035 2006-02-01 Special (immediate Track)
S034 2006-01-17 Real-time Process
S033 2005-12-09 Normal 180 Day Track
S032 2005-12-08 Real-time Process
S031 2005-11-21 Normal 180 Day Track
S030
S029 2005-10-06 135 Review Track For 30-day Notice
S028 2005-10-05 Real-time Process
S027
S026 2005-09-16 Real-time Process
S025 2005-08-23 Real-time Process
S024 2005-06-06 Real-time Process
S023 2005-05-05 Real-time Process
S022 2005-04-15 Normal 180 Day Track No User Fee
S021
S020 2005-01-31 Normal 180 Day Track
S019 2005-01-21 Real-time Process
S018 2004-11-16 Normal 180 Day Track
S017 2004-09-27 Real-time Process
S016 2004-08-27 30-day Notice
S015 2004-06-01 Normal 180 Day Track
S014 2004-05-13 Normal 180 Day Track No User Fee
S013 2004-05-10 Real-time Process
S012 2004-01-28 Normal 180 Day Track No User Fee
S011 2003-11-28 Real-time Process
S010 2003-10-06 Real-time Process
S009 2003-08-22 Normal 180 Day Track No User Fee
S008 2003-08-21 Normal 180 Day Track
S007 2003-08-19 Real-time Process
S006 2003-04-01 Normal 180 Day Track No User Fee
S005 2003-01-27 Normal 180 Day Track
S004 2002-12-03 Normal 180 Day Track
S003 2002-11-13 Normal 180 Day Track
S002 2002-10-02 Real-time Process
S001 2002-09-13 Normal 180 Day Track

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.