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.
Use of additional machines for the manufacturing of the delivery systems for the gore viatorr tips endoprosthesis with and without controlled expansion and the gore viabahn endoprosthesis with and without heparin bioactive surface.
| 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 | 2017-09-11 |
| Decision Date | 2017-10-10 |
| PMA | P130006 |
| Supplement | S043 |
| Product Code | PFV |
| 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 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 |