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.
Alternate fep film supplier and a change from in-process testing to the rawmaterial testing for certain tests performed by the new qualified supplier.
| Device | GORE VIABAHN ENDOPROSTHESIS |
| Classification Name | Stent, Superficial Femoral Artery |
| Generic Name | Stent, Superficial Femoral Artery |
| Applicant | W.L. GORE & ASSOCIATES,INC |
| Date Received | 2013-04-02 |
| Decision Date | 2013-05-02 |
| PMA | P040037 |
| Supplement | S048 |
| 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 |