Valiant Thoracic Stent Graft with Captivia delivery System

FDA Premarket Approval P100040 S052

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

DeviceValiant Thoracic Stent Graft with Captivia delivery System
Generic NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
ApplicantMedtronic Vascular3576 Unocal Placesanta Rosa, CA 95403 PMA NumberP100040 Supplement NumberS052 Date Received09/27/2022 Decision Date10/27/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-09-27
Decision Date2022-10-27
PMAP100040
SupplementS052
Product CodeMIH 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressMedtronic Vascular
3576 Unocal Place
santa Rosa, CA 95403 PMA NumberP100040 Supplement NumberS052 Date Received09/27/2022 Decision Date10/27/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
implementation Of Visual Inspection For A Component Of The Valiant Thoracic Stent Graft With Captivia Delivery System

Supplemental Filings

Supplement NumberDateSupplement Type
P100040Original Filing
S055 2022-11-29 30-day Notice
S054 2022-11-18 30-day Notice
S053 2022-10-31 30-day Notice
S052 2022-09-27 30-day Notice
S051 2022-03-23 30-day Notice
S050 2021-11-30 30-day Notice
S049
S048 2021-07-27 30-day Notice
S047 2021-04-23 Special (immediate Track)
S046 2021-03-17 30-day Notice
S045 2021-03-04 30-day Notice
S044 2021-02-25 30-day Notice
S043
S042
S041 2020-09-04 Normal 180 Day Track No User Fee
S040 2020-07-14 30-day Notice
S039 2019-09-17 30-day Notice
S038 2019-04-05 30-day Notice
S037 2018-09-24 30-day Notice
S036 2018-04-23 Panel Track
S035 2018-04-05 30-day Notice
S034 2018-01-03 30-day Notice
S033 2017-11-20 30-day Notice
S032 2017-07-14 30-day Notice
S031 2017-04-19 30-day Notice
S030
S029 2017-01-12 30-day Notice
S028 2016-08-17 135 Review Track For 30-day Notice
S027 2016-07-13 30-day Notice
S026 2016-06-29 30-day Notice
S025 2015-08-31 135 Review Track For 30-day Notice
S024 2015-08-07 30-day Notice
S023 2015-07-31 30-day Notice
S022 2015-05-26 30-day Notice
S021 2015-05-20 Normal 180 Day Track No User Fee
S020 2015-03-20 135 Review Track For 30-day Notice
S019 2014-04-11 30-day Notice
S018
S017 2014-02-07 Real-time Process
S016 2014-01-31 30-day Notice
S015 2013-12-16 30-day Notice
S014 2013-11-15 30-day Notice
S013 2013-11-04 Real-time Process
S012 2013-07-29 Panel Track
S011 2013-04-04 30-day Notice
S010 2013-01-29 30-day Notice
S009 2012-08-24 30-day Notice
S008 2012-04-30 Panel Track
S007 2012-03-22 135 Review Track For 30-day Notice
S006 2011-06-14 30-day Notice
S005 2011-04-27 Normal 180 Day Track No User Fee
S004 2011-04-27 30-day Notice
S003 2011-04-26 30-day Notice
S002 2011-04-21 30-day Notice
S001 2011-04-05 30-day Notice

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