Gore Excluder AAA Endoprosthesis

FDA Premarket Approval P020004 S173

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

To update the trunk component specifications

DeviceGore Excluder AAA Endoprosthesis
Generic NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
ApplicantW.L. GORE & ASSOCIATES,INC
Date Received2020-02-03
Decision Date2020-03-04
PMAP020004
SupplementS173
Product CodeMIH 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address W.L. GORE & ASSOCIATES,INC 32360 N. North Valley Parkway phoenix, AZ 85085

Supplemental Filings

Supplement NumberDateSupplement Type
P020004Original Filing
S173 2020-02-03 30-day Notice
S172 2019-12-09 Special (immediate Track)
S171 2019-09-27 30-day Notice
S170 2019-09-13 30-day Notice
S169
S168 2019-08-30 30-day Notice
S167
S166
S165 2019-04-15 30-day Notice
S164 2019-03-12 135 Review Track For 30-day Notice
S163 2019-03-01 30-day Notice
S162 2018-12-07 30-day Notice
S161 2018-11-16 30-day Notice
S160 2018-11-14 30-day Notice
S159 2018-09-26 30-day Notice
S158 2018-09-18 30-day Notice
S157 2018-09-12 30-day Notice
S156 2018-06-29 30-day Notice
S155 2018-06-07 30-day Notice
S154 2018-06-01 30-day Notice
S153
S152 2018-04-17 30-day Notice
S151 2018-02-21 30-day Notice
S150 2018-02-20 30-day Notice
S149 2017-11-03 30-day Notice
S148 2017-09-21 30-day Notice
S147 2017-08-29 30-day Notice
S146 2017-07-12 30-day Notice
S145 2017-06-12 30-day Notice
S144 2017-05-26 30-day Notice
S143 2017-05-17 30-day Notice
S142
S141 2016-11-21 30-day Notice
S140 2016-11-21 30-day Notice
S139 2016-11-18 30-day Notice
S138 2016-10-03 30-day Notice
S137 2016-08-02 Normal 180 Day Track No User Fee
S136 2016-07-07 Real-time Process
S135 2016-07-01 30-day Notice
S134 2016-06-24 30-day Notice
S133 2016-06-17 30-day Notice
S132 2016-06-07 30-day Notice
S131 2016-05-10 30-day Notice
S130 2016-04-08 30-day Notice
S129 2016-03-11 30-day Notice
S128 2016-03-11 30-day Notice
S127 2016-03-11 30-day Notice
S126 2016-02-24 Real-time Process
S125 2016-01-29 30-day Notice
S124 2015-11-20 30-day Notice
S123 2015-09-02 Panel Track
S122 2015-08-24 30-day Notice
S121 2015-08-24 30-day Notice
S120 2015-07-21 30-day Notice
S119 2015-06-22 30-day Notice
S118 2015-06-09 30-day Notice
S117 2015-06-04 30-day Notice
S116 2015-05-14 30-day Notice
S115 2015-04-30 30-day Notice
S114 2015-04-27 30-day Notice
S113 2015-04-08 30-day Notice
S112 2015-03-31 30-day Notice
S111 2015-03-02 30-day Notice
S110 2014-12-22 30-day Notice
S109 2014-10-06 30-day Notice
S108 2014-10-03 30-day Notice
S107
S106 2014-09-29 30-day Notice
S105 2014-09-19 30-day Notice
S104 2014-09-19 30-day Notice
S103 2014-08-01 30-day Notice
S102 2014-06-23 30-day Notice
S101 2014-06-04 30-day Notice
S100 2014-06-04 30-day Notice
S099 2014-06-04 30-day Notice
S098 2014-06-04 30-day Notice
S097 2014-06-03 30-day Notice
S096 2014-05-23 30-day Notice
S095 2014-05-23 30-day Notice
S094 2014-04-28 30-day Notice
S093 2014-04-02 30-day Notice
S092 2014-03-25 Real-time Process
S091 2014-01-17 30-day Notice
S090
S089 2013-12-23 30-day Notice
S088 2013-10-22 30-day Notice
S087 2013-09-09 30-day Notice
S086 2013-07-12 30-day Notice
S085 2013-07-16 Real-time Process
S084 2013-06-14 30-day Notice
S083 2013-06-12 30-day Notice
S082 2013-05-21 30-day Notice
S081 2013-04-02 30-day Notice
S080 2012-11-29 30-day Notice
S079 2012-11-27 30-day Notice
S078 2012-11-21 30-day Notice
S077 2012-11-13 30-day Notice
S076 2012-11-06 30-day Notice
S075 2012-10-04 Real-time Process
S074 2012-08-13 Normal 180 Day Track
S073 2012-05-01 30-day Notice
S072 2012-04-20 135 Review Track For 30-day Notice
S071 2012-03-30 30-day Notice
S070 2012-02-07 Real-time Process
S069
S068 2011-12-19 30-day Notice
S067 2011-11-25 30-day Notice
S066 2011-10-07 30-day Notice
S065 2011-09-26 30-day Notice
S064 2011-09-15 Real-time Process
S063 2011-05-11 30-day Notice
S062 2011-05-04 Normal 180 Day Track No User Fee
S061 2011-03-14 30-day Notice
S060 2011-02-28 30-day Notice
S059 2011-02-16 30-day Notice
S058 2011-01-31 30-day Notice
S057 2010-11-15 30-day Notice
S056 2010-11-12 30-day Notice
S055 2010-08-17 30-day Notice
S054 2010-07-07 30-day Notice
S053 2010-05-12 135 Review Track For 30-day Notice
S052 2010-05-06 Normal 180 Day Track
S051 2010-03-12 30-day Notice
S050 2010-03-12 Real-time Process
S049 2009-12-17 135 Review Track For 30-day Notice
S048 2009-10-23 30-day Notice
S047 2009-07-22 30-day Notice
S046 2009-06-30 30-day Notice
S045 2009-06-24 135 Review Track For 30-day Notice
S044 2009-06-17 30-day Notice
S043 2009-02-02 30-day Notice
S042 2009-01-26 30-day Notice
S041 2009-01-14 Real-time Process
S040 2008-11-24 Normal 180 Day Track No User Fee
S039 2008-11-03 Normal 180 Day Track
S038 2008-10-10 30-day Notice
S037 2008-09-03 30-day Notice
S036 2008-05-08 30-day Notice
S035 2008-05-02 Normal 180 Day Track No User Fee
S034 2008-04-30 135 Review Track For 30-day Notice
S033 2008-01-08 30-day Notice
S032 2007-11-06 30-day Notice
S031 2007-10-15 Real-time Process
S030 2007-10-09 30-day Notice
S029 2007-09-20 30-day Notice
S028 2007-09-12 Real-time Process
S027 2007-06-22 135 Review Track For 30-day Notice
S026 2007-06-18 135 Review Track For 30-day Notice
S025 2007-06-08 30-day Notice
S024 2007-05-21 Real-time Process
S023 2007-05-21 Special (immediate Track)
S022 2007-05-11 30-day Notice
S021 2007-04-05 30-day Notice
S020 2007-03-22 30-day Notice
S019 2007-03-08 135 Review Track For 30-day Notice
S018 2006-12-06 30-day Notice
S017
S016 2006-11-06 30-day Notice
S015 2006-08-25 30-day Notice
S014 2005-11-04 30-day Notice
S013 2005-05-24 30-day Notice
S012 2005-05-12 30-day Notice
S011 2005-05-06 Normal 180 Day Track
S010 2005-01-25 135 Review Track For 30-day Notice
S009
S008 2004-11-10 30-day Notice
S007 2004-06-17 Normal 180 Day Track No User Fee
S006 2004-05-10 Normal 180 Day Track
S005 2003-09-02 Normal 180 Day Track
S004 2003-05-27 Normal 180 Day Track
S003 2003-01-31 Normal 180 Day Track
S002 2003-01-03 Normal 180 Day Track
S001 2002-12-31 30-day Notice

NIH GUDID Devices

Device IDPMASupp
H373PXT23141636 P020004 006
00733132609871 P020004 006
00733132609888 P020004 006
00733132609895 P020004 006
00733132609925 P020004 006
00733132609932 P020004 006
00733132609949 P020004 006
00733132609956 P020004 006
00733132609963 P020004 006
00733132610327 P020004 006
00733132610310 P020004 006
H373PXT26121637 P020004 006
H373PXT26121839 P020004 006
H373PXT26121435 P020004 006
00733132610327 P020004 006
00733132610310 P020004 006
H373PXT28141439 P020004 006
00733132610280 P020004 006
H373PXT28121639 P020004 006
H373PXT28121437 P020004 006
00733132610242 P020004 006
H373PXT26141437 P020004 006
00733132609918 P020004 006
H373PXT28141439 P020004 006
00733132610280 P020004 006
H373PXT28121639 P020004 006
H373PXL16140730 P020004 006
H373PXL1612073 P020004 006
H373PXL1610073 P020004 006
00733132610051 P020004 006
00733132610044 P020004 006
00733132610037 P020004 006
00733132610020 P020004 006
00733132610013 P020004 006
00733132610006 P020004 006
00733132609994 P020004 006
H373PXT23121432 P020004 006
H373PXT23121634 P020004 006
H373PXT28121437 P020004 006
00733132610242 P020004 006
H373PXT26141639 P020004 006
H373PXT26141437 P020004 006
H373PXT26121839 P020004 006
00733132609970 P020004 006
H373PXT26121435 P020004 006
H373PXT23141838 P020004 006
H373PXT23141434 P020004 006
H373PXT23121836 P020004 006
00733132609987 P020004 006
H373PXT23141434 P020004 006
00733132610020 P020004 006
00733132610037 P020004 006
00733132610044 P020004 006
00733132610051 P020004 006
H373PXL1610073 P020004 006
H373PXL1612073 P020004 006
H373PXL16140730 P020004 006
H373PXT23121432 P020004 006
H373PXT23121634 P020004 006
H373PXT26121637 P020004 006
H373PXT23121836 P020004 006
H373PXT23141636 P020004 006
H373PXT26141639 P020004 006
00733132610013 P020004 006
00733132610006 P020004 006
H373PXT23141838 P020004 006
00733132609932 P020004 006
00733132609918 P020004 006
00733132609949 P020004 006
00733132609895 P020004 006
00733132609956 P020004 006
00733132609888 P020004 006
00733132609963 P020004 006
00733132609970 P020004 006
00733132609987 P020004 006
00733132609994 P020004 006
00733132609871 P020004 006
00733132609925 P020004 006
H373PXT28121235 P020004 011
H373PXT23141232 P020004 011
H373PXT28141237 P020004 011
H373PXT23121230 P020004 011
H373PXT28121235 P020004 011
H373PXT23121230 P020004 011
H373PXT26141235 P020004 011
H373PXT26121233 P020004 011
H373PXT23141232 P020004 011
H373PXT28141237 P020004 011
H373PXT26141235 P020004 011
H373PXT26121233 P020004 011
00733132609901 P020004 039
H373PXT31141736 P020004 039
H373PXT31141332 P020004 039
H373PXT31141332 P020004 039
H373PXT31141736 P020004 039
H373PXT31141534 P020004 039
H373PXT31141534 P020004 039
00733132609901 P020004 039
00733132618309 P020004 064
00733132618248 P020004 064
00733132618293 P020004 064
00733132618231 P020004 064
00733132618224 P020004 064
00733132618217 P020004 064
00733132618293 P020004 064
00733132618217 P020004 064
00733132618248 P020004 064
00733132618309 P020004 064
00733132618224 P020004 064
00733132618231 P020004 064
00733132618569 P020004 075
00733132618743 P020004 075
00733132618736 P020004 075
00733132618729 P020004 075
00733132618712 P020004 075
00733132618705 P020004 075
00733132618699 P020004 075
H373PLC20120038 P020004 075
00733132618675 P020004 075
00733132618668 P020004 075
00733132618651 P020004 075
00733132618798 P020004 075
00733132618804 P020004 075
00733132618552 P020004 075
00733132618583 P020004 075
H373PLC20100036 P020004 075
00733132618439 P020004 075
00733132618545 P020004 075
00733132618613 P020004 075
00733132618538 P020004 075
00733132618644 P020004 075
00733132618637 P020004 075
H373PLC23100039 P020004 075
00733132618606 P020004 075
00733132618811 P020004 075
00733132618767 P020004 075
H373PLC23100039 P020004 075
00733132618804 P020004 075
00733132618798 P020004 075
00733132618767 P020004 075
00733132618637 P020004 075
00733132618644 P020004 075
00733132618651 P020004 075
00733132618743 P020004 075
00733132618736 P020004 075
00733132618668 P020004 075
00733132618712 P020004 075
00733132618705 P020004 075
00733132618699 P020004 075
H373PLC20120038 P020004 075
00733132618811 P020004 075
00733132618606 P020004 075
00733132618538 P020004 075
00733132618545 P020004 075
00733132618552 P020004 075
00733132618729 P020004 075
00733132618569 P020004 075
00733132618583 P020004 075
H373PLC20100036 P020004 075
00733132618613 P020004 075
00733132618439 P020004 075
00733132618675 P020004 075
H373RMT3114153 P020004 085
H373RMT2314183 P020004 085
H373RMT26141832 P020004 085
H373RMT26141630 P020004 085
H373RMT2612123 P020004 085
H373RMT2812143 P020004 085
H373RMT28121630 P020004 085
H373RMT28121832 P020004 085
H373RMT2814123 P020004 085
H373RMT28141632 P020004 085
H373RMT28141834 P020004 085
H373RMT3114133 P020004 085
H373RMT3114153 P020004 085
H373RMT3114173 P020004 085
H373RLT3114173 P020004 085
H373RLT3114153 P020004 085
00733132619078 P020004 085
H373RLT3514143 P020004 085
H373RLT3514163 P020004 085
H373RLT35141831 P020004 085
H373RMT28141430 P020004 085
H373RMT2812123 P020004 085
00733132610501 P020004 085
H373RMT2614123 P020004 085
H373RMT2614143 P020004 085
H373RMT26141630 P020004 085
H373RMT26141832 P020004 085
H373RMT2812123 P020004 085
H373RMT2812143 P020004 085
H373RMT28121630 P020004 085
H373RMT28121832 P020004 085
H373RMT2814123 P020004 085
H373RMT2612163 P020004 085
H373RMT2612143 P020004 085
H373RMT2312143 P020004 085
H373RMT2312163 P020004 085
H373RMT2312183 P020004 085
H373RMT2314123 P020004 085
H373RMT26121830 P020004 085
H373RMT2314143 P020004 085
H373RMT2314163 P020004 085
H373RMT2314183 P020004 085
H373RMT2612123 P020004 085
H373RMT28141430 P020004 085
H373RMT28141632 P020004 085
H373RMT2612163 P020004 085
H373RMT26121830 P020004 085
H373RMT2614123 P020004 085
H373RLT3114173 P020004 085
H373RLT3114153 P020004 085
00733132619078 P020004 085
H373RLT3514143 P020004 085
H373RLT3514163 P020004 085
H373RLT35141831 P020004 085
H373RMT2612143 P020004 085
H373RMT2314163 P020004 085
H373RMT2314143 P020004 085
H373RMT28141834 P020004 085
H373RMT3114133 P020004 085
H373RMT3114173 P020004 085
00733132610501 P020004 085
H373RMT2312143 P020004 085
H373RMT2312163 P020004 085
H373RMT2312183 P020004 085
H373RMT2314123 P020004 085
H373RMT2614143 P020004 085
00733132618781 P020004 092
00733132622559 P020004 092
00733132622405 P020004 092
00733132622399 P020004 092
00733132622382 P020004 092
00733132622375 P020004 092
00733132622368 P020004 092
00733132622351 P020004 092
00733132622344 P020004 092
00733132622337 P020004 092
00733132622320 P020004 092
00733132618774 P020004 092
00733132618750 P020004 092
00733132622412 P020004 092
00733132622429 P020004 092
00733132622436 P020004 092
00733132622542 P020004 092
00733132622535 P020004 092
00733132622528 P020004 092
00733132622511 P020004 092
H373RLT2812163 P020004 092
00733132622498 P020004 092
00733132622481 P020004 092
00733132622474 P020004 092
00733132622467 P020004 092
00733132622450 P020004 092
00733132622443 P020004 092
00733132618781 P020004 092
00733132622429 P020004 092
00733132622450 P020004 092
00733132622443 P020004 092
00733132622436 P020004 092
00733132618774 P020004 092
00733132622412 P020004 092
00733132622405 P020004 092
00733132622399 P020004 092
00733132622382 P020004 092
00733132622375 P020004 092
00733132622368 P020004 092
00733132622351 P020004 092
00733132622344 P020004 092
00733132622337 P020004 092
00733132622467 P020004 092
00733132622474 P020004 092
00733132622559 P020004 092
00733132618750 P020004 092
00733132622542 P020004 092
00733132622535 P020004 092
00733132622528 P020004 092
00733132622511 P020004 092
H373RLT2812163 P020004 092
00733132622498 P020004 092
00733132622481 P020004 092
00733132622320 P020004 092
00733132635283 P020004 123
00733132635290 P020004 123
00733132635306 P020004 123
00733132635313 P020004 123
00733132635337 P020004 123
00733132635283 P020004 123
00733132635337 P020004 123
00733132635320 P020004 123
00733132635313 P020004 123
00733132635306 P020004 123
00733132635290 P020004 123
00733132635320 P020004 123

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