Approval for alternate manufacturing equipment as well as the changes this equipment introduces into the stent winding and heat treatment process for the gore viatorr tips endoprosthesis and the gore viatorr tips endoprosthesis with controlled expansion
| Device | GORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Conrolled Expansion |
| Generic Name | Shunt, Portosystemic, Endoprosthesis |
| Applicant | W. L. GORE & ASSOCIATES, INC. |
| Date Received | 2019-10-25 |
| Decision Date | 2019-12-06 |
| PMA | P040027 |
| Supplement | S075 |
| 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