GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

Stent, Superficial Femoral Artery

FDA Premarket Approval P040037 S075

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

Approval of the post-approval study protocol.

DeviceGORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
Classification NameStent, Superficial Femoral Artery
Generic NameStent, Superficial Femoral Artery
ApplicantW.L. GORE & ASSOCIATES,INC
Date Received2014-10-14
Decision Date2015-04-03
PMAP040037
SupplementS075
Product CodeNIP
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Osb
Expedited ReviewNo
Combination Product No
Applicant Address W.L. GORE & ASSOCIATES,INC 3450 West Kiltie Ln. p.o. Box 500 flagstaff, AZ 86002-0500

Supplemental Filings

Supplement NumberDateSupplement Type
P040037Original Filing
S155 2022-12-15 30-day Notice
S154 2022-08-08 30-day Notice
S153 2022-02-23 30-day Notice
S152
S151
S150 2022-01-20 30-day Notice
S149 2021-11-08 30-day Notice
S148
S147
S146 2021-08-26 30-day Notice
S145 2021-07-16 30-day Notice
S144 2021-04-06 30-day Notice
S143
S142
S141 2021-01-13 30-day Notice
S140 2020-09-14 30-day Notice
S139 2020-06-16 30-day Notice
S138 2020-05-07 30-day Notice
S137
S136 2020-02-06 30-day Notice
S135 2020-01-03 30-day Notice
S134
S133 2019-08-22 Real-time Process
S132 2019-04-15 30-day Notice
S131 2019-03-20 30-day Notice
S130
S129 2019-03-01 30-day Notice
S128 2019-02-19 30-day Notice
S127 2019-02-04 30-day Notice
S126 2019-01-15 30-day Notice
S125 2018-12-07 30-day Notice
S124 2018-11-15 30-day Notice
S123 2018-11-06 Normal 180 Day Track
S122 2018-09-18 30-day Notice
S121 2018-08-27 30-day Notice
S120 2018-08-24 30-day Notice
S119 2018-07-26 30-day Notice
S118 2018-06-29 30-day Notice
S117 2018-06-07 30-day Notice
S116 2018-06-01 30-day Notice
S115 2018-05-25 30-day Notice
S114 2018-05-03 30-day Notice
S113
S112 2018-04-17 30-day Notice
S111 2018-02-20 30-day Notice
S110 2018-02-06 30-day Notice
S109 2018-01-23 30-day Notice
S108 2017-12-05 30-day Notice
S107 2017-11-03 30-day Notice
S106 2017-10-16 30-day Notice
S105 2017-10-11 135 Review Track For 30-day Notice
S104 2017-09-11 30-day Notice
S103 2017-08-29 30-day Notice
S102 2017-08-23 30-day Notice
S101 2017-08-15 30-day Notice
S100 2017-07-05 30-day Notice
S099 2017-05-26 30-day Notice
S098
S097 2016-12-09 30-day Notice
S096 2016-11-18 30-day Notice
S095 2016-11-08 30-day Notice
S094 2016-10-03 30-day Notice
S093 2016-08-25 30-day Notice
S092 2016-05-17 30-day Notice
S091 2016-04-18 Normal 180 Day Track No User Fee
S090 2016-03-09 30-day Notice
S089 2016-02-03 30-day Notice
S088 2016-01-06 30-day Notice
S087 2015-11-09 30-day Notice
S086 2015-11-02 30-day Notice
S085 2015-07-21 30-day Notice
S084 2015-07-06 30-day Notice
S083 2015-07-01 30-day Notice
S082 2015-07-01 30-day Notice
S081 2015-06-15 Normal 180 Day Track No User Fee
S080 2015-05-14 30-day Notice
S079 2015-05-04 30-day Notice
S078
S077 2015-04-13 30-day Notice
S076 2014-10-23 30-day Notice
S075 2014-10-14 Normal 180 Day Track No User Fee
S074 2014-10-14 Real-time Process
S073 2014-09-29 30-day Notice
S072 2014-09-24 30-day Notice
S071 2014-09-19 30-day Notice
S070 2014-07-01 30-day Notice
S069 2014-06-04 30-day Notice
S068 2014-06-04 30-day Notice
S067 2014-06-04 30-day Notice
S066 2014-06-04 30-day Notice
S065 2014-05-23 30-day Notice
S064 2014-05-19 30-day Notice
S063 2014-04-28 30-day Notice
S062 2014-01-24 Real-time Process
S061 2014-01-06 Real-time Process
S060 2013-12-02 Panel Track
S059 2013-10-22 30-day Notice
S058 2013-10-17 30-day Notice
S057 2013-09-23 30-day Notice
S056 2013-09-23 30-day Notice
S055 2013-09-16 30-day Notice
S054 2013-07-12 30-day Notice
S053 2013-05-20 30-day Notice
S052 2013-05-17 30-day Notice
S051 2013-05-06 30-day Notice
S050 2013-04-29 Normal 180 Day Track
S049 2013-04-15 30-day Notice
S048 2013-04-02 30-day Notice
S047
S046 2013-03-21 30-day Notice
S045 2012-12-13 30-day Notice
S044 2012-12-07 30-day Notice
S043 2012-05-03 30-day Notice
S042 2012-05-01 30-day Notice
S041 2012-01-11 30-day Notice
S040 2012-01-10 30-day Notice
S039 2011-11-07 30-day Notice
S038 2011-10-07 30-day Notice
S037 2011-08-17 30-day Notice
S036 2011-08-10 135 Review Track For 30-day Notice
S035 2011-01-26 30-day Notice
S034 2011-01-20 30-day Notice
S033 2011-01-03 135 Review Track For 30-day Notice
S032 2010-10-28 30-day Notice
S031 2010-10-27 30-day Notice
S030 2010-09-07 Normal 180 Day Track
S029 2010-08-17 30-day Notice
S028 2010-08-09 30-day Notice
S027 2010-07-07 30-day Notice
S026 2010-05-27 30-day Notice
S025 2009-10-23 30-day Notice
S024 2009-08-25 30-day Notice
S023 2009-08-20 30-day Notice
S022 2009-08-04 135 Review Track For 30-day Notice
S021 2009-06-19 30-day Notice
S020 2009-06-09 30-day Notice
S019 2009-05-27 30-day Notice
S018 2009-04-10 30-day Notice
S017 2009-02-24 30-day Notice
S016 2009-02-02 30-day Notice
S015 2009-02-02 30-day Notice
S014 2008-12-15 30-day Notice
S013 2008-12-09 Normal 180 Day Track
S012 2008-11-20 30-day Notice
S011 2008-02-15 30-day Notice
S010 2008-02-11 30-day Notice
S009 2008-01-22 135 Review Track For 30-day Notice
S008
S007 2007-11-20 Panel Track
S006 2007-11-06 30-day Notice
S005 2007-04-02 30-day Notice
S004 2007-03-05 Normal 180 Day Track
S003 2007-01-19 Normal 180 Day Track
S002 2006-08-11 Normal 180 Day Track
S001

NIH GUDID Devices

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00733132645725 P040037 123

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