Requested an alternate ptfe resin used to manufacture the reinforcing film component.
| Device | GORE VIATORR TIPS ENDOPROSTHESIS |
| Classification Name | Shunt, Portosystemic, Endoprosthesis |
| Generic Name | Shunt, Portosystemic, Endoprosthesis |
| Applicant | W. L. GORE & ASSOCIATES, INC. |
| Date Received | 2015-12-08 |
| Decision Date | 2016-01-07 |
| PMA | P040027 |
| Supplement | S047 |
| Product Code | MIR |
| 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. 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