Endurant, Endurant II and Endurant IIs Stent Graft System, Talent Occluder with Occluder Delivery System

FDA Premarket Approval P100021 S090

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

Changing the current pouch sealer with an upgraded pouch sealer

DeviceEndurant, Endurant II and Endurant IIs Stent Graft System, Talent Occluder with Occluder Delivery System
Generic NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
ApplicantMedtronic Vascular
Date Received2021-03-17
Decision Date2021-04-15
PMAP100021
SupplementS090
Product CodeMIH 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Medtronic Vascular 3576 Unocal Place santa Rosa, CA 95403

Supplemental Filings

Supplement NumberDateSupplement Type
P100021Original Filing
S090 2021-03-17 30-day Notice
S089
S088 2021-03-04 30-day Notice
S087 2021-02-25 30-day Notice
S086
S085 2020-10-26 30-day Notice
S084 2020-09-25 30-day Notice
S083 2020-09-04 Normal 180 Day Track No User Fee
S082
S081 2020-07-14 30-day Notice
S080 2020-03-05 30-day Notice
S079 2020-01-08 30-day Notice
S078 2019-09-17 30-day Notice
S077
S076 2019-04-05 30-day Notice
S075 2019-01-22 30-day Notice
S074 2018-09-24 30-day Notice
S073 2018-09-24 30-day Notice
S072 2018-09-10 Normal 180 Day Track No User Fee
S071 2018-04-05 30-day Notice
S070 2018-04-04 30-day Notice
S069 2018-01-03 30-day Notice
S068 2017-11-20 30-day Notice
S067 2017-07-24 30-day Notice
S066 2017-07-18 30-day Notice
S065 2017-07-14 30-day Notice
S064 2017-04-19 30-day Notice
S063 2017-04-03 Panel Track
S062 2017-03-24 30-day Notice
S061
S060 2017-01-04 30-day Notice
S059 2016-12-20 30-day Notice
S058 2016-10-06 Normal 180 Day Track
S057 2016-08-17 135 Review Track For 30-day Notice
S056
S055 2016-07-13 30-day Notice
S054 2016-06-28 135 Review Track For 30-day Notice
S053 2016-05-26 30-day Notice
S052 2016-05-19 30-day Notice
S051 2016-02-02 30-day Notice
S050 2015-10-27 30-day Notice
S049 2015-08-10 30-day Notice
S048 2015-07-10 30-day Notice
S047 2015-04-14 Special (immediate Track)
S046 2015-03-20 135 Review Track For 30-day Notice
S045 2015-02-26 Special (immediate Track)
S044 2014-11-21 Special (immediate Track)
S043 2014-11-20 30-day Notice
S042 2014-11-07 30-day Notice
S041 2014-10-28 Real-time Process
S040 2014-09-03 30-day Notice
S039 2014-07-25 Real-time Process
S038 2014-06-09 Special (immediate Track)
S037 2014-04-25 30-day Notice
S036 2014-04-15 Special (immediate Track)
S035 2014-04-15 Special (immediate Track)
S034 2014-04-10 30-day Notice
S033 2014-01-31 30-day Notice
S032 2013-12-26 Normal 180 Day Track No User Fee
S031 2013-12-16 30-day Notice
S030 2013-11-15 30-day Notice
S029 2013-09-30 30-day Notice
S028 2013-08-14 30-day Notice
S027 2013-07-25 Special (immediate Track)
S026 2013-05-28 30-day Notice
S025 2013-04-04 30-day Notice
S024 2013-03-20 Normal 180 Day Track No User Fee
S023 2013-02-25 30-day Notice
S022 2012-10-22 30-day Notice
S021 2012-10-11 Normal 180 Day Track
S020 2012-08-27 30-day Notice
S019 2012-06-12 30-day Notice
S018 2012-05-18 Normal 180 Day Track No User Fee
S017 2012-05-09 30-day Notice
S016 2012-04-03 30-day Notice
S015 2012-03-22 135 Review Track For 30-day Notice
S014 2012-03-22 30-day Notice
S013 2012-01-30 30-day Notice
S012 2011-11-10 Normal 180 Day Track No User Fee
S011 2011-11-02 Normal 180 Day Track
S010 2011-08-18 Special (immediate Track)
S009 2011-07-11 30-day Notice
S008 2011-04-21 30-day Notice
S007 2011-03-04 30-day Notice
S006 2011-03-01 30-day Notice
S005 2011-02-18 30-day Notice
S004 2011-02-14 135 Review Track For 30-day Notice
S003
S002 2011-01-14 Normal 180 Day Track No User Fee
S001 2011-01-12 30-day Notice

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