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.
Implement changes to the viabahn stent graft stripping machine used in the manufacture of the gore viabahn endoprosthesis and gore viabahn endoprosthesis with heparin bioactive surface.
| Device | GORE VIABAHN Endoprosthesis |
| Classification Name | Stent, Superficial Femoral Artery |
| Generic Name | Stent, Superficial Femoral Artery |
| Applicant | W.L. GORE & ASSOCIATES,INC |
| Date Received | 2018-02-06 |
| Decision Date | 2018-03-06 |
| PMA | P040037 |
| Supplement | S110 |
| Product Code | NIP |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |
| 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 |