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.
Approval for the addition of a 25cm length for the 5-8mm diameter endoprostheses. The device, as modified, will be marketed under the trade name gore viabahn endoprosthesis and gore viabahn endoprosthesis with heparin bioactive surface and is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery lesions up to 230 mm in length with reference vessel diameters ranging from 4. 0 ¿ 7. 5 mm. The gore viabahn endoprosthesis and gore viabahn endoprosthesis with heparin bioactive surface are also indicated for improving blood flow in patients with symptomatic peripheral arterial disease in iliac artery lesions up to 80 mm in length with reference vessel diameters ranging from 4. 0 ¿ 12 mm.
| Device | GORE VIABAHN ENDOPROSTHESIS, GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE |
| Classification Name | Stent, Superficial Femoral Artery |
| Generic Name | Stent, Superficial Femoral Artery |
| Applicant | W.L. GORE & ASSOCIATES,INC |
| Date Received | 2013-04-29 |
| Decision Date | 2013-10-18 |
| PMA | P040037 |
| Supplement | S050 |
| Product Code | NIP |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | W.L. GORE & ASSOCIATES,INC 3450 West Kiltie Ln. p.o. Box 500 flagstaff, AZ 86002-0500 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P040037 | Original 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 |