Pipeline Flex Embolization

FDA Premarket Approval P100018 S028

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 labeling changes to the instructions for use to strengthen information about possible device component separation, fracture, or breakage in the warnings, cautions and potential complications sections.

DevicePipeline Flex Embolization
Generic NameIntracranial Aneurysm Flow Diverter
ApplicantMicro Therapeutics, Inc. D/b/a Ev3 NEUROVASCULAR
Date Received2020-08-24
Decision Date2020-09-21
PMAP100018
SupplementS028
Product CodeOUT 
Advisory CommitteeNeurology
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Micro Therapeutics, Inc. D/b/a Ev3 NEUROVASCULAR 9775 Toledo Way irvine, CA 92618

Supplemental Filings

Supplement NumberDateSupplement Type
P100018Original Filing
S028 2020-08-24 Special (immediate Track)
S027 2020-06-02 30-day Notice
S026
S025
S024
S023 2019-08-22 30-day Notice
S022
S021 2019-07-05 30-day Notice
S020 2019-04-26 30-day Notice
S019 2018-11-29 30-day Notice
S018 2018-09-24 30-day Notice
S017 2017-12-15 Normal 180 Day Track No User Fee
S016 2017-09-14 30-day Notice
S015 2017-06-28 Panel Track
S014 2016-03-03 30-day Notice
S013 2014-10-06 Special (immediate Track)
S012 2014-07-21 30-day Notice
S011 2014-06-26 Normal 180 Day Track
S010 2014-01-28 30-day Notice
S009
S008 2013-07-22 Real-time Process
S007 2013-04-11 30-day Notice
S006 2013-03-12 30-day Notice
S005 2012-12-21 Special (immediate Track)
S004 2011-09-19 Normal 180 Day Track No User Fee
S003 2011-08-01 Special (immediate Track)
S002
S001 2011-04-28 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
00847536009806 P100018 004
00847536009394 P100018 004
00847536009370 P100018 004
00847536009332 P100018 004
00847536009318 P100018 004
00847536009271 P100018 004
00847536009257 P100018 004
00847536009219 P100018 004
00847536009196 P100018 004
00847536009158 P100018 004
00847536009448 P100018 004
00847536009462 P100018 004
00847536009509 P100018 004
00847536009769 P100018 004
00847536009745 P100018 004
00847536009707 P100018 004
00847536009684 P100018 004
00847536009646 P100018 004
00847536009622 P100018 004
00847536009585 P100018 004
00847536009561 P100018 004
00847536009523 P100018 004
00847536009134 P100018 004
00847536009097 P100018 004
00847536008687 P100018 004
00847536008632 P100018 004
00847536008618 P100018 004
00847536008571 P100018 004
00847536008557 P100018 004
00847536008519 P100018 004
00847536008496 P100018 004
00847536008458 P100018 004
00847536008434 P100018 004
00847536008700 P100018 004
00847536008755 P100018 004
00847536008779 P100018 004
00847536009073 P100018 004
00847536009035 P100018 004
00847536009011 P100018 004
00847536008977 P100018 004
00847536008953 P100018 004
00847536008915 P100018 004
00847536008892 P100018 004
00847536008847 P100018 004
00847536008823 P100018 004
00847536008397 P100018 004
00847536011007 P100018 004
00847536010659 P100018 004
00847536010635 P100018 004
00847536010604 P100018 004
00847536010581 P100018 004
00847536010550 P100018 004
00847536010536 P100018 004
00847536010505 P100018 004
00847536010482 P100018 004
00847536010451 P100018 004
00847536010680 P100018 004
00847536010703 P100018 004
00847536010734 P100018 004
00847536010963 P100018 004
00847536010949 P100018 004
00847536010901 P100018 004
00847536010888 P100018 004
00847536010857 P100018 004
00847536010833 P100018 004
00847536010802 P100018 004
00847536010789 P100018 004
00847536010758 P100018 004
00847536010437 P100018 004
00847536010406 P100018 004
00847536010086 P100018 004
00847536010055 P100018 004
00847536010031 P100018 004
00847536010000 P100018 004
00847536009981 P100018 004
00847536009943 P100018 004
00847536009929 P100018 004
00847536009882 P100018 004
00847536009868 P100018 004
00847536010109 P100018 004
00847536010130 P100018 004
00847536010154 P100018 004
00847536010383 P100018 004
00847536010352 P100018 004
00847536010338 P100018 004
00847536010307 P100018 004
00847536010284 P100018 004
00847536010253 P100018 004
00847536010239 P100018 004
00847536010208 P100018 004
00847536010185 P100018 004
00847536009820 P100018 004
00847536008373 P100018 004
00836462014541 P100018 004
00836462014411 P100018 004
00836462014404 P100018 004
00836462014398 P100018 004
00836462014381 P100018 004
00836462014374 P100018 004
00836462014367 P100018 004
00836462014350 P100018 004
00836462014343 P100018 004
00836462014336 P100018 004
00836462014428 P100018 004
00836462014435 P100018 004
00836462014442 P100018 004
00836462014534 P100018 004
00836462014527 P100018 004
00836462014510 P100018 004
00836462014503 P100018 004
00836462014497 P100018 004
00836462014480 P100018 004
00836462014473 P100018 004
00836462014466 P100018 004
00836462014459 P100018 004
00836462014329 P100018 004
00836462014312 P100018 004
00836462014183 P100018 004
00836462014176 P100018 004
00836462014169 P100018 004
00836462014152 P100018 004
00836462014145 P100018 004
00836462014138 P100018 004
00836462014121 P100018 004
00836462014114 P100018 004
00836462014107 P100018 004
00836462014190 P100018 004
00836462014206 P100018 004
00836462014213 P100018 004
00836462014305 P100018 004
00836462014299 P100018 004
00836462014282 P100018 004
00836462014275 P100018 004
00836462014268 P100018 004
00836462014251 P100018 004
00836462014244 P100018 004
00836462014237 P100018 004
00836462014220 P100018 004
00836462014091 P100018 004
00836462014084 P100018 004
00836462014886 P100018 004
00836462014879 P100018 004
00836462014862 P100018 004
00836462014855 P100018 004
00836462014848 P100018 004
00836462014831 P100018 004
00836462014824 P100018 004
00836462014817 P100018 004
00836462014800 P100018 004
00836462014893 P100018 004
00836462014909 P100018 004
00836462014916 P100018 004
00836462015005 P100018 004
00836462014992 P100018 004
00836462014985 P100018 004
00836462014978 P100018 004
00836462014961 P100018 004
00836462014954 P100018 004
00836462014947 P100018 004
00836462014930 P100018 004
00836462014923 P100018 004
00836462014794 P100018 004
00836462014787 P100018 004
00836462014640 P100018 004
00836462014633 P100018 004
00836462014626 P100018 004
00836462014619 P100018 004
00836462014602 P100018 004
00836462014596 P100018 004
00836462014589 P100018 004
00836462014572 P100018 004
00836462014565 P100018 004
00836462014657 P100018 004
00836462014671 P100018 004
00836462014688 P100018 004
00836462014770 P100018 004
00836462014763 P100018 004
00836462014756 P100018 004
00836462014749 P100018 004
00836462014732 P100018 004
00836462014725 P100018 004
00836462014718 P100018 004
00836462014701 P100018 004
00836462014695 P100018 004
00836462014558 P100018 004
00847536011021 P100018 004
00847536012455 P100018 004
00847536012868 P100018 004
00847536012905 P100018 004
00847536012929 P100018 004
00847536012967 P100018 004
00847536012981 P100018 004
00847536019164 P100018 004
00847536019287 P100018 004
00847536019584 P100018 004
00847536019560 P100018 004
00847536012844 P100018 004
00847536012806 P100018 004
00847536012783 P100018 004
00847536012493 P100018 004
00847536012516 P100018 004
00847536012554 P100018 004
00847536012578 P100018 004
00847536012615 P100018 004
00847536012639 P100018 004
00847536012677 P100018 004
00847536012721 P100018 004
00847536012745 P100018 004
00847536019522 P100018 004
00847536019508 P100018 004
00847536019041 P100018 004
00847536019027 P100018 004
00847536018983 P100018 004
00847536018969 P100018 004
00847536018921 P100018 004
00847536018907 P100018 004
00847536018860 P100018 004
00847536018846 P100018 004
00847536018815 P100018 004
00847536019089 P100018 004
00847536019102 P100018 004
00847536019140 P100018 004
00847536019461 P100018 004
00847536019447 P100018 004
00847536019409 P100018 004
00847536019386 P100018 004
00847536019348 P100018 004
00847536019324 P100018 004
00847536019263 P100018 004
00847536019225 P100018 004
00847536019201 P100018 004
00836462014664 P100018 004
00847536012431 P100018 004
00847536011069 P100018 004
00847536011489 P100018 004
00847536011502 P100018 004
00847536011540 P100018 004
00847536011564 P100018 004
00847536011601 P100018 004
00847536011625 P100018 004
00847536011663 P100018 004
00847536011687 P100018 004
00847536011724 P100018 004
00847536011748 P100018 004
00847536011441 P100018 004
00847536011427 P100018 004
00847536011380 P100018 004
00847536011083 P100018 004
00847536011120 P100018 004
00847536011144 P100018 004
00847536011182 P100018 004
00847536011205 P100018 004
00847536011243 P100018 004
00847536011267 P100018 004
00847536011304 P100018 004
00847536011328 P100018 004
00847536011366 P100018 004
00847536011786 P100018 004
00847536011809 P100018 004
00847536012035 P100018 004
00847536012073 P100018 004
00847536012097 P100018 004
00847536012134 P100018 004
00847536012158 P100018 004
00847536012196 P100018 004
00847536012219 P100018 004
00847536012257 P100018 004
00847536012271 P100018 004
00847536012318 P100018 004
00847536012332 P100018 004
00847536012370 P100018 004
00847536012394 P100018 004
00847536011847 P100018 004
00847536011861 P100018 004
00847536011908 P100018 004
00847536011922 P100018 004
00847536011960 P100018 004
00847536011984 P100018 004
00847536012011 P100018 004
00847536015609 P100018 011
00847536015579 P100018 011
00847536015548 P100018 011
00847536015517 P100018 011
00847536015487 P100018 011
00847536015456 P100018 011
00847536015784 P100018 011
00847536015425 P100018 011
00847536015630 P100018 011
00847536015661 P100018 011
00847536015692 P100018 011
00847536015722 P100018 011
00847536015753 P100018 011
00847536015937 P100018 011
00847536015906 P100018 011
00847536015876 P100018 011
00847536015845 P100018 011
00847536015814 P100018 011
00847536015395 P100018 011
00847536015364 P100018 011
00836462015067 P100018 011
00836462015074 P100018 011
00836462015098 P100018 011
00836462015081 P100018 011
00836462015142 P100018 011
00836462015135 P100018 011
00836462015128 P100018 011
00836462015111 P100018 011
00836462015050 P100018 011
00836462015043 P100018 011
00847536015333 P100018 011
00847536015302 P100018 011
00847536015272 P100018 011
00847536015241 P100018 011
00847536015210 P100018 011
00836462015012 P100018 011
00836462015029 P100018 011
00836462015036 P100018 011
00836462015104 P100018 011
00847536015968 P100018 011
00847536015999 P100018 011
00847536016620 P100018 011
00847536016651 P100018 011
00847536016682 P100018 011
00847536016712 P100018 011
00847536016743 P100018 011
00847536016774 P100018 011
00847536016804 P100018 011
00847536016835 P100018 011
00847536016866 P100018 011
00847536016897 P100018 011
00847536016903 P100018 011
00836462015241 P100018 011
00847536019638 P100018 011
00847536019669 P100018 011
00847536019690 P100018 011
00847536019720 P100018 011
00847536019751 P100018 011
00847536016590 P100018 011
00847536016569 P100018 011
00847536016538 P100018 011
00847536016026 P100018 011
00847536016057 P100018 011
00847536016088 P100018 011
00847536016118 P100018 011
00847536016149 P100018 011
00847536016200 P100018 011
00847536016170 P100018 011
00847536016231 P100018 011
00847536016262 P100018 011
00847536016293 P100018 011
00847536016323 P100018 011
00847536016354 P100018 011
00847536016385 P100018 011
00847536016415 P100018 011
00847536016446 P100018 011
00847536016477 P100018 011
00847536016507 P100018 011
00847536019782 P100018 011
00836462015692 P100018 011
00836462015838 P100018 011
00836462015845 P100018 011
00836462015852 P100018 011
00836462015869 P100018 011
00836462015876 P100018 011
00836462015883 P100018 011
00836462015890 P100018 011
00836462015906 P100018 011
00836462015913 P100018 011
00836462015920 P100018 011
00836462015937 P100018 011
00836462015821 P100018 011
00836462015814 P100018 011
00836462015708 P100018 011
00836462015715 P100018 011
00836462015722 P100018 011
00836462015739 P100018 011
00836462015746 P100018 011
00836462015753 P100018 011
00836462015760 P100018 011
00836462015777 P100018 011
00836462015784 P100018 011
00836462015791 P100018 011
00836462015807 P100018 011
00847536015159 P100018 011
00847536015128 P100018 011
00847536015098 P100018 011
00847536014671 P100018 011
00847536014640 P100018 011
00847536014619 P100018 011
00847536014589 P100018 011
00847536014558 P100018 011
00847536014527 P100018 011
00847536014497 P100018 011
00847536014466 P100018 011
00847536014435 P100018 011
00847536014404 P100018 011
00847536014374 P100018 011
00847536014701 P100018 011
00847536014732 P100018 011
00847536015067 P100018 011
00847536015036 P100018 011
00847536015005 P100018 011
00847536014978 P100018 011
00847536014947 P100018 011
00847536014916 P100018 011
00847536014886 P100018 011
00847536014855 P100018 011
00847536014824 P100018 011
00847536014794 P100018 011
00847536014763 P100018 011
00847536014343 P100018 011
00836462015685 P100018 011
00836462015159 P100018 011
00836462015296 P100018 011
00836462015302 P100018 011
00836462015319 P100018 011
00836462015326 P100018 011
00836462015333 P100018 011
00836462015340 P100018 011
00836462015357 P100018 011
00836462015364 P100018 011
00836462015371 P100018 011
00836462015388 P100018 011
00836462015395 P100018 011
00836462015289 P100018 011
00836462015272 P100018 011
00836462015166 P100018 011
00836462015173 P100018 011
00836462015180 P100018 011
00836462015197 P100018 011
00836462015203 P100018 011
00836462015210 P100018 011
00836462015227 P100018 011
00836462015234 P100018 011
00847536015180 P100018 011
00836462015258 P100018 011
00836462015265 P100018 011
00836462015401 P100018 011
00836462015418 P100018 011
00836462015425 P100018 011
00836462015562 P100018 011
00836462015579 P100018 011
00836462015586 P100018 011
00836462015593 P100018 011
00836462015609 P100018 011
00836462015616 P100018 011
00836462015623 P100018 011
00836462015630 P100018 011
00836462015647 P100018 011
00836462015654 P100018 011
00836462015661 P100018 011
00836462015555 P100018 011
00836462015548 P100018 011
00836462015432 P100018 011
00836462015449 P100018 011
00836462015456 P100018 011
00836462015463 P100018 011
00836462015470 P100018 011
00836462015487 P100018 011
00836462015494 P100018 011
00836462015500 P100018 011
00836462015517 P100018 011
00836462015524 P100018 011
00836462015531 P100018 011
00836462015678 P100018 011

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.