EverFlex Self-Expanding Peripheral Stent Systems and EverFlex Self-Expanding Peripheral Stent with Entrust Delivery Syst

Stent, Superficial Femoral Artery

FDA Premarket Approval P110023 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

Labeling updates with the final results of the durability post-approval study

DeviceEverFlex Self-Expanding Peripheral Stent Systems and EverFlex Self-Expanding Peripheral Stent with Entrust Delivery Syst
Classification NameStent, Superficial Femoral Artery
Generic NameStent, Superficial Femoral Artery
ApplicantMEDTRONIC VASCULAR INC
Date Received2019-08-27
Decision Date2019-11-20
PMAP110023
SupplementS028
Product CodeNIP
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLabeling Change - Pas
Expedited ReviewNo
Combination Product No
Applicant Address MEDTRONIC VASCULAR INC 3033 Campus Drive plymouth, MN 55441

Supplemental Filings

Supplement NumberDateSupplement Type
P110023Original Filing
S028 2019-08-27 Normal 180 Day Track No User Fee
S027 2019-05-24 30-day Notice
S026 2019-05-03 30-day Notice
S025 2019-02-19 30-day Notice
S024 2017-11-03 30-day Notice
S023 2016-12-07 30-day Notice
S022 2016-11-02 30-day Notice
S021 2016-09-28 Normal 180 Day Track No User Fee
S020 2016-07-05 30-day Notice
S019 2016-06-06 30-day Notice
S018 2016-03-22 30-day Notice
S017
S016 2015-11-20 30-day Notice
S015 2015-03-23 135 Review Track For 30-day Notice
S014 2015-03-15 30-day Notice
S013 2014-11-17 30-day Notice
S012 2014-08-22 Normal 180 Day Track
S011 2014-07-21 30-day Notice
S010 2014-07-10 Normal 180 Day Track No User Fee
S009 2014-06-05 30-day Notice
S008 2014-06-03 30-day Notice
S007 2014-04-14 Panel Track
S006 2014-02-03 Normal 180 Day Track No User Fee
S005
S004 2012-10-09 30-day Notice
S003 2012-06-11 30-day Notice
S002 2012-05-16 30-day Notice
S001 2012-04-24 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00821684069141 P110023 000
00821684069271 P110023 000
00821684069288 P110023 000
00821684069295 P110023 000
00821684069301 P110023 000
00821684069318 P110023 000
00821684069325 P110023 000
00821684069332 P110023 000
00821684069349 P110023 000
00821684069356 P110023 000
00821684069363 P110023 000
00821684069264 P110023 000
00821684069257 P110023 000
00821684069158 P110023 000
00821684069165 P110023 000
00821684069172 P110023 000
00821684069189 P110023 000
00821684069196 P110023 000
00821684069202 P110023 000
00821684069219 P110023 000
00821684069226 P110023 000
00821684069233 P110023 000
00821684069240 P110023 000
00821684069370 P110023 000
00821684069387 P110023 000
00821684069394 P110023 000
00821684069523 P110023 000
00821684069530 P110023 000
00821684069547 P110023 000
00821684069554 P110023 000
00821684069561 P110023 000
00821684069578 P110023 000
00821684069585 P110023 000
00821684069592 P110023 000
00821684069608 P110023 000
00821684069615 P110023 000
00821684069516 P110023 000
00821684069509 P110023 000
00821684069400 P110023 000
00821684069417 P110023 000
00821684069424 P110023 000
00821684069431 P110023 000
00821684069448 P110023 000
00821684069455 P110023 000
00821684069462 P110023 000
00821684069479 P110023 000
00821684069486 P110023 000
00821684069493 P110023 000
00821684068946 P110023 000
00821684069134 P110023 000
00821684068632 P110023 000
00821684068762 P110023 000
00821684068779 P110023 000
00821684068786 P110023 000
00821684068793 P110023 000
00821684068809 P110023 000
00821684068816 P110023 000
00821684068823 P110023 000
00821684068830 P110023 000
00821684068847 P110023 000
00821684068854 P110023 000
00821684068755 P110023 000
00821684068748 P110023 000
00821684068649 P110023 000
00821684068656 P110023 000
00821684068663 P110023 000
00821684068670 P110023 000
00821684068687 P110023 000
00821684068694 P110023 000
00821684068700 P110023 000
00821684068717 P110023 000
00821684068724 P110023 000
00821684068731 P110023 000
00821684068861 P110023 000
00821684068878 P110023 000
00821684068885 P110023 000
00821684069028 P110023 000
00821684069035 P110023 000
00821684069042 P110023 000
00821684069059 P110023 000
00821684069066 P110023 000
00821684069073 P110023 000
00821684069080 P110023 000
00821684069097 P110023 000
00821684069103 P110023 000
00821684069110 P110023 000
00821684069011 P110023 000
00821684069004 P110023 000
00821684068892 P110023 000
00821684068908 P110023 000
00821684068915 P110023 000
00821684068922 P110023 000
00821684068939 P110023 000
00821684068953 P110023 000
00821684068960 P110023 000
00821684068977 P110023 000
00821684068984 P110023 000
00821684068991 P110023 000
00821684069127 P110023 000
00821684069059 P110023 000
00821684068915 P110023 000
00821684068908 P110023 000
00821684068892 P110023 000
00821684068885 P110023 000
00821684068878 P110023 000
00821684068861 P110023 000
00821684068854 P110023 000
00821684068847 P110023 000
00821684068830 P110023 000
00821684068823 P110023 000
00821684068922 P110023 000
00821684068939 P110023 000
00821684068946 P110023 000
00821684069042 P110023 000
00821684069035 P110023 000
00821684069028 P110023 000
00821684069011 P110023 000
00821684069004 P110023 000
00821684068991 P110023 000
00821684068984 P110023 000
00821684068977 P110023 000
00821684068960 P110023 000
00821684068953 P110023 000
00821684068816 P110023 000
00821684068809 P110023 000
00821684068663 P110023 000
00821684068656 P110023 000
00821684068649 P110023 000
00821684069134 P110023 000
00821684069110 P110023 000
00821684069578 P110023 000
00821684068632 P110023 000
00821684069615 P110023 000
00821684069608 P110023 000
00821684069592 P110023 000
00821684068670 P110023 000
00821684069561 P110023 000
00821684068694 P110023 000
00821684068793 P110023 000
00821684068786 P110023 000
00821684068779 P110023 000
00821684068762 P110023 000
00821684068755 P110023 000
00821684068748 P110023 000
00821684068731 P110023 000
00821684068724 P110023 000
00821684068717 P110023 000
00821684068700 P110023 000
00821684069585 P110023 000
00821684069066 P110023 000
00821684069530 P110023 000
00821684069394 P110023 000
00821684069387 P110023 000
00821684069370 P110023 000
00821684069363 P110023 000
00821684069356 P110023 000
00821684069349 P110023 000
00821684069332 P110023 000
00821684069325 P110023 000
00821684069318 P110023 000
00821684069547 P110023 000
00821684069400 P110023 000
00821684069417 P110023 000
00821684069424 P110023 000
00821684069523 P110023 000
00821684069516 P110023 000
00821684069509 P110023 000
00821684069493 P110023 000
00821684069486 P110023 000
00821684069479 P110023 000
00821684069462 P110023 000
00821684069455 P110023 000
00821684069448 P110023 000
00821684069431 P110023 000
00821684069301 P110023 000
00821684069295 P110023 000
00821684069165 P110023 000
00821684069158 P110023 000
00821684069141 P110023 000
00821684069080 P110023 000
00821684069554 P110023 000
00821684068687 P110023 000
00821684069127 P110023 000
00821684069073 P110023 000
00821684069103 P110023 000
00821684069097 P110023 000
00821684069172 P110023 000
00821684069189 P110023 000
00821684069196 P110023 000
00821684069257 P110023 000
00821684069240 P110023 000
00821684069233 P110023 000
00821684069226 P110023 000
00821684069264 P110023 000
00821684069271 P110023 000
00821684069288 P110023 000
00821684069219 P110023 000
00821684069202 P110023 000
00821684033821 P110023 004
00821684034200 P110023 004
00821684034194 P110023 004
00821684034187 P110023 004
00821684034170 P110023 004
00821684034217 P110023 004
00821684034224 P110023 004
00821684034231 P110023 004
00821684034323 P110023 004
00821684034316 P110023 004
00821684034309 P110023 004
00821684034293 P110023 004
00821684034279 P110023 004
00821684034262 P110023 004
00821684034255 P110023 004
00821684034248 P110023 004
00821684034286 P110023 004
00821684033920 P110023 004
00821684033753 P110023 004
00821684033760 P110023 004
00821684033777 P110023 004
00821684033784 P110023 004
00821684033807 P110023 004
00821684033814 P110023 004
00821684034378 P110023 004
00821684033838 P110023 004
00821684033845 P110023 004
00821684033852 P110023 004
00821684033869 P110023 004
00821684033876 P110023 004
00821684033883 P110023 004
00821684033890 P110023 004
00821684033906 P110023 004
00821684033913 P110023 004
00821684033869 P110023 004
00821684034330 P110023 004
00821684034309 P110023 004
00821684033920 P110023 004
00821684034170 P110023 004
00821684034187 P110023 004
00821684034194 P110023 004
00821684034200 P110023 004
00821684034217 P110023 004
00821684034224 P110023 004
00821684034231 P110023 004
00821684034248 P110023 004
00821684034255 P110023 004
00821684051481 P110023 004
00821684034262 P110023 004
00821684034279 P110023 004
00821684034286 P110023 004
00821684034293 P110023 004
00821684034316 P110023 004
00821684033913 P110023 004
00821684033906 P110023 004
00821684033890 P110023 004
00821684033753 P110023 004
00821684033760 P110023 004
00821684033777 P110023 004
00821684033791 P110023 004
00821684033784 P110023 004
00821684033791 P110023 004
00821684033807 P110023 004
00821684051726 P110023 004
00821684033814 P110023 004
00821684033821 P110023 004
00821684033838 P110023 004
00821684033845 P110023 004
00821684033852 P110023 004
00821684033876 P110023 004
00821684051641 P110023 004
00821684033883 P110023 004
00821684034323 P110023 004
00821684051405 P110023 004
00821684034347 P110023 004
00821684051481 P110023 004
00821684049532 P110023 004
00821684049525 P110023 004
00821684049518 P110023 004
00821684042922 P110023 004
00821684042915 P110023 004
00821684042908 P110023 004
00821684042892 P110023 004
00821684042885 P110023 004
00821684042878 P110023 004
00821684034408 P110023 004
00821684034392 P110023 004
00821684034385 P110023 004
00821684042878 P110023 004
00821684034361 P110023 004
00821684034354 P110023 004
00821684051405 P110023 004
00821684051641 P110023 004
00821684051726 P110023 004
00821684034347 P110023 004
00821684034354 P110023 004
00821684034361 P110023 004
00821684034378 P110023 004
00821684034385 P110023 004
00821684034392 P110023 004
00821684034408 P110023 004
00821684042885 P110023 004
00821684042892 P110023 004
00821684042908 P110023 004
00821684049525 P110023 004
00821684049518 P110023 004
00821684034330 P110023 004
00821684042922 P110023 004
00821684042915 P110023 004
00821684049532 P110023 004
00821684059944 P110023 007
00821684059951 P110023 007
00821684059968 P110023 007
00821684059975 P110023 007
00821684059982 P110023 007
00821684060001 P110023 007
00821684060018 P110023 007
00821684060025 P110023 007
00821684060032 P110023 007
00821684059937 P110023 007
00821684059920 P110023 007
00821684060070 P110023 007
00821684059838 P110023 007
00821684059999 P110023 007
00821684059845 P110023 007
00821684059852 P110023 007
00821684059869 P110023 007
00821684059876 P110023 007
00821684059883 P110023 007
00821684059890 P110023 007
00821684059906 P110023 007
00821684059913 P110023 007
00821684060049 P110023 007
00821684060056 P110023 007
00821684060223 P110023 007
00821684060230 P110023 007
00821684060247 P110023 007
00821684060254 P110023 007
00821684060261 P110023 007
00821684060278 P110023 007
00821684060094 P110023 007
00821684060285 P110023 007
00821684060292 P110023 007
00821684060308 P110023 007
00821684060315 P110023 007
00821684060322 P110023 007
00821684060216 P110023 007
00821684060209 P110023 007
00821684060063 P110023 007
00821684060087 P110023 007
00821684060100 P110023 007
00821684060117 P110023 007
00821684060124 P110023 007
00821684060131 P110023 007
00821684060148 P110023 007
00821684060155 P110023 007
00821684060162 P110023 007
00821684060179 P110023 007
00821684060186 P110023 007
00821684060193 P110023 007
00821684060339 P110023 007
00821684060292 P110023 007
00821684060131 P110023 007
00821684060308 P110023 007
00821684060117 P110023 007
00821684060100 P110023 007
00821684060094 P110023 007
00821684060087 P110023 007
00821684060070 P110023 007
00821684060063 P110023 007
00821684060056 P110023 007
00821684060049 P110023 007
00821684060032 P110023 007
00821684060025 P110023 007
00821684060018 P110023 007
00821684060148 P110023 007
00821684060155 P110023 007
00821684060285 P110023 007
00821684060278 P110023 007
00821684060261 P110023 007
00821684060254 P110023 007
00821684060247 P110023 007
00821684060230 P110023 007
00821684060223 P110023 007
00821684060216 P110023 007
00821684060209 P110023 007
00821684060193 P110023 007
00821684060186 P110023 007
00821684060179 P110023 007
00821684060162 P110023 007
00821684060001 P110023 007
00821684059999 P110023 007
00821684059982 P110023 007
00821684059852 P110023 007
00821684059838 P110023 007
00821684060339 P110023 007
00821684060315 P110023 007
00821684059883 P110023 007
00821684060124 P110023 007
00821684059845 P110023 007
00821684060322 P110023 007
00821684059906 P110023 007
00821684059869 P110023 007
00821684059876 P110023 007
00821684059975 P110023 007
00821684059951 P110023 007
00821684059944 P110023 007
00821684059937 P110023 007
00821684059920 P110023 007
00821684059913 P110023 007
00821684059968 P110023 007
00821684059890 P110023 007
00821684051344 P110023 012
00821684051337 P110023 012
00821684051498 P110023 012
00821684051368 P110023 012
00821684051375 P110023 012
00821684051320 P110023 012
00821684051351 P110023 012
00821684051474 P110023 012
00821684051467 P110023 012
00821684051450 P110023 012
00821684051443 P110023 012
00821684051429 P110023 012
00821684051399 P110023 012
00821684051436 P110023 012
00821684051382 P110023 012
00821684051412 P110023 012
00821684051313 P110023 012
00821684051306 P110023 012
00821684051214 P110023 012
00821684051207 P110023 012
00821684051191 P110023 012
00821684051184 P110023 012
00821684051177 P110023 012
00821684051160 P110023 012
00821684051153 P110023 012
00821684051139 P110023 012
00821684051122 P110023 012
00821684051283 P110023 012
00821684051238 P110023 012
00821684051146 P110023 012
00821684051245 P110023 012
00821684051252 P110023 012
00821684051269 P110023 012
00821684051276 P110023 012
00821684051290 P110023 012
00821684051221 P110023 012
00821684051504 P110023 012
00821684051306 P110023 012
00821684051436 P110023 012
00821684051443 P110023 012
00821684051450 P110023 012
00821684051467 P110023 012
00821684051474 P110023 012
00821684051498 P110023 012
00821684051504 P110023 012
00821684051511 P110023 012
00821684051528 P110023 012
00821684051429 P110023 012
00821684051412 P110023 012
00821684051313 P110023 012
00821684051320 P110023 012
00821684051337 P110023 012
00821684051344 P110023 012
00821684051351 P110023 012
00821684051368 P110023 012
00821684051375 P110023 012
00821684051382 P110023 012
00821684051399 P110023 012
00821684051535 P110023 012
00821684051542 P110023 012
00821684051689 P110023 012
00821684051696 P110023 012
00821684051702 P110023 012
00821684051719 P110023 012
00821684051733 P110023 012
00821684051740 P110023 012
00821684051757 P110023 012
00821684051771 P110023 012
00821684051788 P110023 012
00821684051672 P110023 012
00821684051665 P110023 012
00821684051559 P110023 012
00821684051573 P110023 012
00821684051580 P110023 012
00821684051597 P110023 012
00821684051603 P110023 012
00821684051610 P110023 012
00821684051627 P110023 012
00821684051634 P110023 012
00821684051658 P110023 012
00821684051795 P110023 012
00821684051290 P110023 012
00821684051511 P110023 012
00821684051658 P110023 012
00821684051665 P110023 012
00821684051672 P110023 012
00821684051689 P110023 012
00821684051696 P110023 012
00821684051702 P110023 012
00821684051719 P110023 012
00821684051733 P110023 012
00821684051740 P110023 012
00821684051634 P110023 012
00821684051627 P110023 012
00821684051528 P110023 012
00821684051535 P110023 012
00821684051542 P110023 012
00821684051559 P110023 012
00821684051573 P110023 012
00821684051580 P110023 012
00821684051597 P110023 012
00821684051603 P110023 012
00821684051610 P110023 012
00821684051757 P110023 012
00821684051764 P110023 012
00821684051184 P110023 012
00821684051191 P110023 012
00821684051207 P110023 012
00821684051214 P110023 012
00821684051221 P110023 012
00821684051238 P110023 012
00821684051245 P110023 012
00821684051252 P110023 012
00821684051269 P110023 012
00821684051177 P110023 012
00821684051160 P110023 012
00821684051771 P110023 012
00821684051788 P110023 012
00821684051795 P110023 012
00821684051276 P110023 012
00821684051764 P110023 012
00821684051122 P110023 012
00821684051139 P110023 012
00821684051146 P110023 012
00821684051153 P110023 012
00821684051283 P110023 012

© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.