This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the gore viabahn endoprosthesis. The device is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery lesions with reference vessel diameters ranging from 4. 8 to 7. 5 mm.
| Device | VIABAHN ENDOPROSTHESIS |
| Classification Name | Stent, Superficial Femoral Artery |
| Generic Name | Stent, Superficial Femoral Artery |
| Applicant | W.L. GORE & ASSOCIATES,INC |
| Date Received | 2004-08-27 |
| Decision Date | 2005-06-14 |
| Notice Date | 2005-09-23 |
| PMA | P040037 |
| Supplement | S |
| Product Code | NIP |
| Docket Number | 05M-0379 |
| Advisory Committee | Cardiovascular |
| 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 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |