Approval for the gore viatorr tips endoprosthesis. The device is indicated for use in de novo and revision treatment of portal hypertension and its complications such as variceal bleeding, gastropathy, ascites, and/or hepatic hydrothorax.
| Device | GORE VIATORR TIPS |
| Classification Name | Shunt, Portosystemic, Endoprosthesis |
| Generic Name | Shunt, Portosystemic, Endoprosthesis |
| Applicant | W. L. GORE & ASSOCIATES, INC. |
| Date Received | 2004-06-09 |
| Decision Date | 2004-12-06 |
| Notice Date | 2006-10-17 |
| PMA | P040027 |
| Supplement | S |
| Product Code | MIR |
| Docket Number | 06M-0411 |
| Advisory Committee | Cardiovascular |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | W. L. GORE & ASSOCIATES, INC. 32360 N North Valley Parkway phoenix, AZ 85085 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P040027 | | Original Filing |
| S092 |
2022-07-25 |
30-day Notice |
| S091 |
2022-06-27 |
30-day Notice |
| S090 |
2022-01-20 |
30-day Notice |
| S089 | | |
| S088 |
2021-08-26 |
30-day Notice |
| S087 |
2021-04-06 |
30-day Notice |
| S086 | | |
| S085 |
2021-02-19 |
30-day Notice |
| S084 |
2021-02-19 |
30-day Notice |
| S083 | | |
| S082 |
2021-01-13 |
30-day Notice |
| S081 |
2020-11-24 |
30-day Notice |
| S080 |
2020-11-19 |
30-day Notice |
| S079 |
2020-06-16 |
30-day Notice |
| S078 |
2020-02-06 |
30-day Notice |
| S077 |
2020-01-03 |
30-day Notice |
| S076 |
2019-11-18 |
30-day Notice |
| S075 |
2019-10-25 |
30-day Notice |
| S074 | | |
| S073 |
2019-04-15 |
30-day Notice |
| S072 | | |
| S071 |
2019-03-01 |
30-day Notice |
| S070 |
2019-02-19 |
30-day Notice |
| S069 |
2018-12-07 |
30-day Notice |
| S068 |
2018-10-18 |
30-day Notice |
| S067 |
2018-09-18 |
30-day Notice |
| S066 |
2018-08-27 |
30-day Notice |
| S065 |
2018-06-29 |
30-day Notice |
| S064 |
2018-06-07 |
30-day Notice |
| S063 |
2018-06-01 |
30-day Notice |
| S062 | | |
| S061 |
2018-04-17 |
30-day Notice |
| S060 |
2018-04-16 |
30-day Notice |
| S059 |
2017-09-11 |
30-day Notice |
| S058 |
2017-08-29 |
30-day Notice |
| S057 |
2017-05-26 |
30-day Notice |
| S056 |
2017-05-12 |
30-day Notice |
| S055 | | |
| S054 |
2017-01-18 |
Real-time Process |
| S053 |
2016-12-12 |
30-day Notice |
| S052 |
2016-11-07 |
Special (immediate Track) |
| S051 |
2016-10-03 |
30-day Notice |
| S050 |
2016-09-06 |
30-day Notice |
| S049 |
2016-08-25 |
30-day Notice |
| S048 |
2016-02-22 |
Normal 180 Day Track |
| S047 |
2015-12-08 |
30-day Notice |
| S046 |
2015-11-16 |
30-day Notice |
| S045 |
2015-07-21 |
30-day Notice |
| S044 |
2015-05-14 |
30-day Notice |
| S043 |
2015-05-05 |
30-day Notice |
| S042 |
2015-04-30 |
30-day Notice |
| S041 |
2015-03-04 |
30-day Notice |
| S040 |
2015-02-18 |
30-day Notice |
| S039 |
2014-11-28 |
30-day Notice |
| S038 |
2014-09-29 |
30-day Notice |
| S037 |
2014-06-04 |
30-day Notice |
| S036 |
2014-06-04 |
30-day Notice |
| S035 |
2014-06-04 |
30-day Notice |
| S034 |
2014-06-04 |
30-day Notice |
| S033 |
2014-04-28 |
30-day Notice |
| S032 |
2013-09-16 |
30-day Notice |
| S031 |
2013-07-12 |
30-day Notice |
| S030 |
2013-04-17 |
30-day Notice |
| S029 |
2013-04-02 |
30-day Notice |
| S028 |
2012-05-01 |
30-day Notice |
| S027 | | |
| S026 |
2011-10-07 |
30-day Notice |
| S025 |
2011-09-30 |
30-day Notice |
| S024 |
2011-03-24 |
Normal 180 Day Track No User Fee |
| S023 | | |
| S022 |
2010-08-02 |
30-day Notice |
| S021 |
2010-08-02 |
30-day Notice |
| S020 |
2010-07-07 |
30-day Notice |
| S019 |
2010-02-12 |
135 Review Track For 30-day Notice |
| S018 |
2009-10-23 |
30-day Notice |
| S017 |
2009-08-25 |
30-day Notice |
| S016 |
2009-07-02 |
30-day Notice |
| S015 |
2009-06-19 |
30-day Notice |
| S014 |
2009-03-18 |
30-day Notice |
| S013 |
2009-02-02 |
30-day Notice |
| S012 |
2008-03-03 |
30-day Notice |
| S011 |
2008-02-26 |
30-day Notice |
| S010 |
2008-01-22 |
135 Review Track For 30-day Notice |
| S009 |
2007-12-07 |
135 Review Track For 30-day Notice |
| S008 |
2007-11-06 |
30-day Notice |
| S007 |
2007-09-12 |
Real-time Process |
| S006 |
2007-08-24 |
30-day Notice |
| S005 |
2007-05-15 |
30-day Notice |
| S004 |
2007-04-02 |
30-day Notice |
| S003 |
2006-10-12 |
Special (immediate Track) |
| S002 |
2005-09-19 |
135 Review Track For 30-day Notice |
| S001 |
2004-12-16 |
30-day Notice |
NIH GUDID Devices