Additional supplier of films used in the manufacturing of the gore excluder aaa endoprosthesis, gore viatorr tips endoprosthesis, gore tag thoracic endoprosthesis, gore cardioform septal occluder, and gore viabhan endoprosthesis with and without heparin bioactive surface.
| Device | GORE CADIOFORM Septal Occluder |
| Classification Name | Transcatheter Septal Occluder |
| Generic Name | Transcatheter Septal Occluder |
| Applicant | W.L. GORE & ASSOCIATES,INC |
| Date Received | 2017-08-29 |
| Decision Date | 2017-09-27 |
| PMA | P050006 |
| Supplement | S061 |
| Product Code | MLV |
| 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 85085-1505 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P050006 | | Original Filing |
| S105 |
2022-12-15 |
30-day Notice |
| S104 |
2022-11-18 |
Special (immediate Track) |
| S103 | | |
| S102 |
2022-09-09 |
30-day Notice |
| S101 | | |
| S100 |
2022-06-06 |
Normal 180 Day Track No User Fee |
| S099 |
2022-04-28 |
30-day Notice |
| S098 |
2022-01-20 |
30-day Notice |
| S097 |
2022-01-18 |
30-day Notice |
| S096 |
2021-11-19 |
30-day Notice |
| S095 |
2021-10-28 |
30-day Notice |
| S094 |
2021-07-16 |
30-day Notice |
| S093 | | |
| S092 |
2021-04-06 |
30-day Notice |
| S091 | | |
| S090 | | |
| S089 |
2021-01-15 |
30-day Notice |
| S088 |
2021-01-13 |
30-day Notice |
| S087 |
2020-11-24 |
30-day Notice |
| S086 | | |
| S085 |
2020-07-27 |
Normal 180 Day Track No User Fee |
| S084 |
2020-06-03 |
Real-time Process |
| S083 |
2020-06-02 |
Special (immediate Track) |
| S082 |
2020-03-02 |
30-day Notice |
| S081 |
2019-10-22 |
30-day Notice |
| S080 |
2019-10-02 |
30-day Notice |
| S079 | | |
| S078 |
2019-06-26 |
30-day Notice |
| S077 | | |
| S076 |
2019-03-27 |
30-day Notice |
| S075 |
2019-03-12 |
135 Review Track For 30-day Notice |
| S074 |
2019-03-01 |
30-day Notice |
| S073 |
2019-03-01 |
30-day Notice |
| S072 |
2018-12-07 |
30-day Notice |
| S071 | | |
| S070 |
2018-06-29 |
30-day Notice |
| S069 |
2018-06-01 |
Normal 180 Day Track |
| S068 |
2018-05-24 |
30-day Notice |
| S067 |
2018-04-26 |
Normal 180 Day Track No User Fee |
| S066 | | |
| S065 |
2018-04-17 |
30-day Notice |
| S064 |
2018-03-20 |
30-day Notice |
| S063 |
2018-03-07 |
30-day Notice |
| S062 |
2018-02-26 |
30-day Notice |
| S061 |
2017-08-29 |
30-day Notice |
| S060 |
2017-07-31 |
Panel Track |
| S059 |
2017-05-17 |
30-day Notice |
| S058 |
2017-02-16 |
135 Review Track For 30-day Notice |
| S057 | | |
| S056 |
2016-12-09 |
30-day Notice |
| S055 |
2016-11-16 |
30-day Notice |
| S054 |
2016-10-03 |
30-day Notice |
| S053 |
2016-09-26 |
30-day Notice |
| S052 |
2016-09-14 |
30-day Notice |
| S051 |
2016-07-27 |
30-day Notice |
| S050 |
2016-02-26 |
30-day Notice |
| S049 |
2016-01-11 |
30-day Notice |
| S048 |
2015-07-31 |
30-day Notice |
| S047 |
2015-05-14 |
30-day Notice |
| S046 |
2015-02-18 |
30-day Notice |
| S045 |
2015-01-23 |
30-day Notice |
| S044 |
2014-11-03 |
Normal 180 Day Track |
| S043 |
2014-09-29 |
30-day Notice |
| S042 |
2014-06-04 |
30-day Notice |
| S041 |
2014-06-04 |
30-day Notice |
| S040 |
2014-06-04 |
30-day Notice |
| S039 |
2014-06-04 |
30-day Notice |
| S038 |
2014-04-28 |
30-day Notice |
| S037 |
2013-10-22 |
30-day Notice |
| S036 |
2013-07-12 |
30-day Notice |
| S035 |
2013-06-17 |
Special (immediate Track) |
| S034 |
2013-06-05 |
30-day Notice |
| S033 |
2012-11-30 |
30-day Notice |
| S032 |
2012-10-09 |
30-day Notice |
| S031 |
2012-09-05 |
30-day Notice |
| S030 |
2012-08-17 |
30-day Notice |
| S029 |
2012-08-06 |
135 Review Track For 30-day Notice |
| S028 |
2012-05-02 |
30-day Notice |
| S027 |
2012-05-01 |
30-day Notice |
| S026 |
2011-10-20 |
30-day Notice |
| S025 |
2011-10-18 |
30-day Notice |
| S024 |
2011-10-07 |
30-day Notice |
| S023 |
2011-09-30 |
30-day Notice |
| S022 |
2011-09-29 |
30-day Notice |
| S021 |
2011-09-23 |
30-day Notice |
| S020 |
2011-06-16 |
135 Review Track For 30-day Notice |
| S019 |
2011-01-20 |
30-day Notice |
| S018 |
2010-08-17 |
30-day Notice |
| S017 |
2010-07-07 |
30-day Notice |
| S016 |
2010-02-26 |
Normal 180 Day Track |
| S015 |
2009-10-23 |
30-day Notice |
| S014 |
2009-09-17 |
Normal 180 Day Track |
| S013 |
2009-07-23 |
30-day Notice |
| S012 |
2009-06-11 |
135 Review Track For 30-day Notice |
| S011 |
2009-03-17 |
135 Review Track For 30-day Notice |
| S010 |
2009-02-02 |
30-day Notice |
| S009 |
2008-12-19 |
30-day Notice |
| S008 |
2008-05-22 |
30-day Notice |
| S007 |
2008-05-14 |
30-day Notice |
| S006 |
2008-04-07 |
30-day Notice |
| S005 |
2007-11-06 |
30-day Notice |
| S004 |
2007-09-27 |
135 Review Track For 30-day Notice |
| S003 |
2007-04-19 |
30-day Notice |
| S002 |
2006-10-16 |
Normal 180 Day Track No User Fee |
| S001 |
2006-09-12 |
Normal 180 Day Track |
NIH GUDID Devices