ENDURANT IIS STENT GRAFT SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Premarket Approval P100021 S042

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

Addition of an alternate supplier for the secondary and tertiary packagingfor endurant iis stent graft systems, as well as a change in configuration for the e-beam sterilization process.

DeviceENDURANT IIS STENT GRAFT SYSTEM
Classification NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
Generic NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
ApplicantMedtronic Vascular
Date Received2014-11-07
Decision Date2014-11-25
PMAP100021
SupplementS042
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
S111 2022-11-29 30-day Notice
S110 2022-11-18 30-day Notice
S109 2022-11-01 30-day Notice
S108 2022-10-31 30-day Notice
S107 2022-09-28 30-day Notice
S106
S105 2022-07-27 30-day Notice
S104 2022-04-15 30-day Notice
S103 2022-03-23 30-day Notice
S102 2022-03-11 Special (immediate Track)
S101 2022-01-25 30-day Notice
S100 2022-01-10 30-day Notice
S099 2021-12-07 30-day Notice
S098 2021-12-07 30-day Notice
S097 2021-11-17 30-day Notice
S096 2021-10-20 Special (immediate Track)
S095 2021-08-31 30-day Notice
S094 2021-07-27 30-day Notice
S093
S092 2021-04-28 Normal 180 Day Track No User Fee
S091 2021-04-23 Special (immediate Track)
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

NIH GUDID Devices

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