For a change to the device instructions for use to add a warning related to risks associated with physician modification of the device before use
| Device | GORE CARDIOFORM ASD Occluder |
| Generic Name | Transcatheter Septal Occluder |
| Applicant | W.L. GORE & ASSOCIATES,INC |
| Date Received | 2020-06-02 |
| Decision Date | 2020-07-02 |
| PMA | P050006 |
| Supplement | S083 |
| Product Code | MLV |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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