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 and the gore viabahn endoprosthesis with heparin bioactive surface. This device is indicated for the treatment of stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous (av) access grafts.
| Device | GORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE |
| Classification Name | System, Endovascular Graft, Arteriovenous (av) Dialysis Access Circuit Stenosis Treatment |
| Generic Name | System, Endovascular Graft, Arteriovenous (av) Dialysis Access Circuit Stenosis Treatment |
| Applicant | W.L. GORE & ASSOCIATES,INC |
| Date Received | 2013-04-01 |
| Decision Date | 2013-12-05 |
| Notice Date | 2013-12-24 |
| PMA | P130006 |
| Supplement | S |
| Product Code | PFV |
| Docket Number | 13M-1605 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | W.L. GORE & ASSOCIATES,INC 3250 W.kiltie Lane flagstaff, AZ 86001 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P130006 | Original Filing | |
| S094 | 2022-12-15 | 30-day Notice |
| S093 | 2022-08-08 | 30-day Notice |
| S092 | 2022-02-23 | 30-day Notice |
| S091 | ||
| S090 | ||
| S089 | 2022-01-20 | 30-day Notice |
| S088 | 2021-11-08 | 30-day Notice |
| S087 | ||
| S086 | 2021-10-14 | 30-day Notice |
| S085 | 2021-08-26 | 30-day Notice |
| S084 | 2021-07-16 | 30-day Notice |
| S083 | 2021-04-06 | 30-day Notice |
| S082 | ||
| S081 | ||
| S080 | 2021-01-13 | 30-day Notice |
| S079 | 2020-09-14 | 30-day Notice |
| S078 | 2020-06-16 | 30-day Notice |
| S077 | 2020-05-07 | 30-day Notice |
| S076 | 2020-05-04 | 30-day Notice |
| S075 | 2020-02-06 | 30-day Notice |
| S074 | 2020-01-03 | 30-day Notice |
| S073 | ||
| S072 | 2019-08-22 | Real-time Process |
| S071 | 2019-04-15 | 30-day Notice |
| S070 | 2019-03-20 | 30-day Notice |
| S069 | ||
| S068 | 2019-03-01 | 30-day Notice |
| S067 | 2019-02-19 | 30-day Notice |
| S066 | 2019-02-04 | 30-day Notice |
| S065 | 2019-01-15 | 30-day Notice |
| S064 | 2018-12-07 | 30-day Notice |
| S063 | 2018-11-15 | 30-day Notice |
| S062 | 2018-11-06 | Normal 180 Day Track |
| S061 | 2018-09-18 | 30-day Notice |
| S060 | 2018-08-27 | 30-day Notice |
| S059 | 2018-08-24 | 30-day Notice |
| S058 | 2018-07-26 | 30-day Notice |
| S057 | 2018-06-29 | 30-day Notice |
| S056 | 2018-06-07 | 30-day Notice |
| S055 | 2018-06-01 | 30-day Notice |
| S054 | 2018-05-25 | 30-day Notice |
| S053 | 2018-05-03 | 30-day Notice |
| S052 | ||
| S051 | 2018-04-17 | 30-day Notice |
| S050 | 2018-02-20 | 30-day Notice |
| S049 | 2018-02-06 | 30-day Notice |
| S048 | 2018-01-23 | 30-day Notice |
| S047 | 2017-12-05 | 30-day Notice |
| S046 | 2017-11-03 | 30-day Notice |
| S045 | 2017-10-16 | 30-day Notice |
| S044 | 2017-10-11 | 135 Review Track For 30-day Notice |
| S043 | 2017-09-11 | 30-day Notice |
| S042 | 2017-08-29 | 30-day Notice |
| S041 | 2017-08-23 | 30-day Notice |
| S040 | 2017-08-15 | 30-day Notice |
| S039 | 2017-07-05 | 30-day Notice |
| S038 | 2017-05-26 | 30-day Notice |
| S037 | ||
| S036 | 2016-12-09 | 30-day Notice |
| S035 | 2016-11-18 | 30-day Notice |
| S034 | 2016-11-08 | 30-day Notice |
| S033 | 2016-10-03 | 30-day Notice |
| S032 | 2016-08-25 | 30-day Notice |
| S031 | 2016-05-17 | 30-day Notice |
| S030 | 2016-04-18 | Normal 180 Day Track No User Fee |
| S029 | 2016-03-09 | 30-day Notice |
| S028 | 2016-02-03 | 30-day Notice |
| S027 | 2016-01-06 | 30-day Notice |
| S026 | 2015-11-09 | 30-day Notice |
| S025 | 2015-11-02 | 30-day Notice |
| S024 | 2015-07-21 | 30-day Notice |
| S023 | 2015-07-06 | 30-day Notice |
| S022 | 2015-07-01 | 30-day Notice |
| S021 | 2015-07-01 | 30-day Notice |
| S020 | 2015-06-15 | Normal 180 Day Track No User Fee |
| S019 | 2015-05-14 | 30-day Notice |
| S018 | 2015-05-04 | 30-day Notice |
| S017 | ||
| S016 | 2015-04-13 | 30-day Notice |
| S015 | 2014-10-23 | 30-day Notice |
| S014 | 2014-10-14 | Real-time Process |
| S013 | 2014-09-29 | 30-day Notice |
| S012 | 2014-09-24 | 30-day Notice |
| S011 | 2014-09-19 | 30-day Notice |
| S010 | 2014-07-01 | 30-day Notice |
| S009 | 2014-06-04 | 30-day Notice |
| S008 | 2014-06-04 | 30-day Notice |
| S007 | 2014-06-04 | 30-day Notice |
| S006 | 2014-06-04 | 30-day Notice |
| S005 | 2014-05-23 | 30-day Notice |
| S004 | 2014-05-19 | 30-day Notice |
| S003 | 2014-04-28 | 30-day Notice |
| S002 | 2014-02-18 | Real-time Process |
| S001 | 2014-02-18 | Real-time Process |