Approval for the sapien xt transcatheter heart valve (thv), model 9300tfx, and accessories. This device is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis (aortic valve area = 4. 0 m/s), and with native anatomy appropriate for the 23, 26, or 29 mm valve system, who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i. E. , society of thoracic surgeons operative risk score >=8% or at a >=15% risk of mortality at 30 days).
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P130009 | | Original Filing |
| S113 |
2021-02-22 |
30-day Notice |
| S112 |
2020-10-28 |
30-day Notice |
| S111 |
2020-08-10 |
30-day Notice |
| S110 |
2020-06-26 |
30-day Notice |
| S109 | | |
| S108 |
2020-02-07 |
30-day Notice |
| S107 | | |
| S106 | | |
| S105 | | |
| S104 |
2019-11-01 |
30-day Notice |
| S103 |
2019-10-18 |
30-day Notice |
| S102 |
2019-09-27 |
30-day Notice |
| S101 | | |
| S100 |
2019-08-30 |
Special (immediate Track) |
| S099 | | |
| S098 | | |
| S097 |
2019-02-21 |
30-day Notice |
| S096 |
2019-01-31 |
30-day Notice |
| S095 |
2018-11-14 |
30-day Notice |
| S094 |
2018-10-31 |
30-day Notice |
| S093 |
2018-08-09 |
30-day Notice |
| S092 |
2018-07-09 |
30-day Notice |
| S091 |
2018-06-28 |
30-day Notice |
| S090 |
2018-05-25 |
30-day Notice |
| S089 |
2018-04-23 |
30-day Notice |
| S088 |
2018-03-26 |
30-day Notice |
| S087 |
2018-03-13 |
30-day Notice |
| S086 |
2018-03-05 |
30-day Notice |
| S085 |
2018-03-01 |
30-day Notice |
| S084 |
2018-02-02 |
30-day Notice |
| S083 |
2017-10-31 |
30-day Notice |
| S082 |
2017-09-11 |
30-day Notice |
| S081 |
2017-06-30 |
30-day Notice |
| S080 |
2017-06-27 |
30-day Notice |
| S079 |
2017-06-22 |
30-day Notice |
| S078 |
2017-06-19 |
30-day Notice |
| S077 |
2017-05-25 |
30-day Notice |
| S076 |
2017-05-24 |
30-day Notice |
| S075 | | |
| S074 |
2017-04-25 |
30-day Notice |
| S073 |
2017-04-10 |
30-day Notice |
| S072 |
2017-03-24 |
30-day Notice |
| S071 |
2017-03-23 |
30-day Notice |
| S070 |
2017-02-13 |
30-day Notice |
| S069 |
2017-01-11 |
30-day Notice |
| S068 |
2016-11-16 |
Normal 180 Day Track No User Fee |
| S067 |
2016-11-17 |
30-day Notice |
| S066 |
2016-11-15 |
135 Review Track For 30-day Notice |
| S065 |
2016-10-11 |
30-day Notice |
| S064 |
2016-08-22 |
30-day Notice |
| S063 |
2016-07-05 |
30-day Notice |
| S062 |
2016-07-01 |
Normal 180 Day Track No User Fee |
| S061 |
2016-06-30 |
Normal 180 Day Track No User Fee |
| S060 |
2016-06-02 |
Special (immediate Track) |
| S059 |
2016-05-25 |
30-day Notice |
| S058 |
2016-05-16 |
Special (immediate Track) |
| S057 |
2016-05-02 |
Panel Track |
| S056 | | |
| S055 |
2016-04-12 |
30-day Notice |
| S054 |
2016-03-28 |
Special (immediate Track) |
| S053 |
2016-03-23 |
Normal 180 Day Track No User Fee |
| S052 |
2016-03-18 |
30-day Notice |
| S051 |
2016-03-01 |
30-day Notice |
| S050 |
2016-02-18 |
30-day Notice |
| S049 |
2016-02-17 |
30-day Notice |
| S048 |
2016-02-05 |
30-day Notice |
| S047 |
2016-01-20 |
Special (immediate Track) |
| S046 |
2016-01-19 |
Special (immediate Track) |
| S045 |
2016-01-15 |
30-day Notice |
| S044 |
2015-12-14 |
30-day Notice |
| S043 |
2015-12-07 |
30-day Notice |
| S042 |
2015-11-23 |
30-day Notice |
| S041 |
2015-09-30 |
30-day Notice |
| S040 |
2015-07-27 |
30-day Notice |
| S039 |
2015-07-24 |
30-day Notice |
| S038 |
2015-07-10 |
Real-time Process |
| S037 |
2015-07-01 |
Panel Track |
| S036 |
2015-05-22 |
30-day Notice |
| S035 |
2015-05-18 |
30-day Notice |
| S034 |
2015-04-15 |
Panel Track |
| S033 | | |
| S032 |
2015-03-17 |
30-day Notice |
| S031 |
2015-03-17 |
30-day Notice |
| S030 | | |
| S029 |
2015-02-18 |
30-day Notice |
| S028 |
2015-02-09 |
135 Review Track For 30-day Notice |
| S027 |
2015-02-02 |
30-day Notice |
| S026 |
2015-01-30 |
30-day Notice |
| S025 |
2015-01-28 |
30-day Notice |
| S024 |
2015-01-13 |
30-day Notice |
| S023 |
2015-01-09 |
30-day Notice |
| S022 |
2015-01-08 |
30-day Notice |
| S021 | | |
| S020 | | |
| S019 |
2014-12-03 |
30-day Notice |
| S018 |
2014-11-17 |
30-day Notice |
| S017 |
2014-11-14 |
30-day Notice |
| S016 |
2014-11-13 |
135 Review Track For 30-day Notice |
| S015 |
2014-10-17 |
30-day Notice |
| S014 |
2014-10-10 |
30-day Notice |
| S013 |
2014-10-07 |
30-day Notice |
| S012 |
2014-09-22 |
30-day Notice |
| S011 |
2014-09-04 |
30-day Notice |
| S010 |
2014-09-03 |
30-day Notice |
| S009 |
2014-09-02 |
30-day Notice |
| S008 | | |
| S007 | | |
| S006 | | |
| S005 |
2014-07-21 |
30-day Notice |
| S004 |
2014-07-17 |
135 Review Track For 30-day Notice |
| S003 |
2014-07-15 |
30-day Notice |
| S002 |
2014-07-14 |
Normal 180 Day Track No User Fee |
| S001 |
2014-07-18 |
30-day Notice |
NIH GUDID Devices