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 a post-approval study labeling update regarding revisions to the instructions for use to include the final study results for the reline extended follow-up study.
| Device | GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN 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 | 2015-06-15 |
| Decision Date | 2015-10-14 |
| PMA | P130006 |
| Supplement | S020 |
| Product Code | PFV |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Pas |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | W.L. GORE & ASSOCIATES,INC 3250 W.kiltie Lane flagstaff, AZ 86001 |
| 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 |