Approval to change certain manufacturing processes from a manual process to a semi-automated process. The device, as modified, will be marketed under the trade name gore viatorr tips endoprosthesis and 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 ENDOPROSTHESIS |
| Classification Name | Shunt, Portosystemic, Endoprosthesis |
| Generic Name | Shunt, Portosystemic, Endoprosthesis |
| Applicant | W. L. GORE & ASSOCIATES, INC. |
| Date Received | 2005-09-19 |
| Decision Date | 2005-12-08 |
| PMA | P040027 |
| Supplement | S002 |
| Product Code | MIR |
| Advisory Committee | Cardiovascular |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | W. L. GORE & ASSOCIATES, INC. 32360 N North Valley Parkway phoenix, AZ 85085 |
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