AFX Endovascular AAA System

FDA Premarket Approval P040002 S065

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

An added destructive test to the process monitoring control for the afx2 bifurcated device

DeviceAFX Endovascular AAA System
Generic NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
ApplicantENDOLOGIX, INC.
Date Received2020-06-26
Decision Date2020-07-23
PMAP040002
SupplementS065
Product CodeMIH 
Advisory CommitteeCardiovascular
Supplement TypeSpecial (immediate Track)
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ENDOLOGIX, INC. 11 Studebaker irvine, CA 92618

Supplemental Filings

Supplement NumberDateSupplement Type
P040002Original Filing
S065 2020-06-26 Special (immediate Track)
S064
S063 2019-07-19 30-day Notice
S062
S061 2018-07-10 Special (immediate Track)
S060 2018-04-02 Real-time Process
S059 2017-04-07 Special (immediate Track)
S058 2017-02-07 135 Review Track For 30-day Notice
S057 2015-11-02 30-day Notice
S056 2015-10-19 30-day Notice
S055 2015-07-28 Real-time Process
S054 2015-05-19 Special (immediate Track)
S053 2014-07-16 Special (immediate Track)
S052 2014-06-12 30-day Notice
S051 2014-06-12 30-day Notice
S050 2014-06-12 30-day Notice
S049 2014-06-12 Real-time Process
S048 2014-06-12 Real-time Process
S047 2014-05-09 Normal 180 Day Track No User Fee
S046 2014-01-06 135 Review Track For 30-day Notice
S045 2013-12-17 Normal 180 Day Track No User Fee
S044 2013-11-12 Real-time Process
S043 2013-07-12 Real-time Process
S042 2013-07-05 Real-time Process
S041 2013-05-02 Real-time Process
S040 2012-11-08 Real-time Process
S039 2012-07-05 Normal 180 Day Track
S038 2012-07-05 Real-time Process
S037 2012-03-13 Real-time Process
S036 2012-01-17 30-day Notice
S035 2011-11-01 Real-time Process
S034 2011-10-13 30-day Notice
S033 2011-08-29 30-day Notice
S032 2011-05-31 30-day Notice
S031 2010-12-16 Normal 180 Day Track
S030 2010-11-26 30-day Notice
S029 2010-11-18 Real-time Process
S028 2010-04-08 30-day Notice
S027 2010-03-25 Real-time Process
S026 2010-02-05 Normal 180 Day Track
S025 2009-09-01 Normal 180 Day Track
S024 2009-06-09 135 Review Track For 30-day Notice
S023 2009-01-22 Real-time Process
S022 2008-10-06 Normal 180 Day Track
S021 2008-09-08 Real-time Process
S020 2008-07-23 30-day Notice
S019 2008-07-01 Normal 180 Day Track
S018 2008-04-22 Normal 180 Day Track
S017 2008-04-11 Real-time Process
S016
S015 2008-02-29 Real-time Process
S014 2007-12-26 Real-time Process
S013 2007-12-26 Normal 180 Day Track No User Fee
S012 2007-04-19 30-day Notice
S011 2007-03-16 30-day Notice
S010 2007-03-15 30-day Notice
S009 2007-02-28 30-day Notice
S008 2006-12-19 30-day Notice
S007 2006-09-29 Real-time Process
S006
S005 2006-03-20 Real-time Process
S004 2006-02-21 Real-time Process
S003 2006-01-10 30-day Notice
S002 2005-11-10 Normal 180 Day Track No User Fee
S001 2004-12-03 Normal 180 Day Track No User Fee

NIH GUDID Devices

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