Approval for the edwards sapien 3 transcatheter heart valve, model 9600tfx, and accessories. This device is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis 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 |
|---|
| P140031 | | Original Filing |
| S151 |
2023-01-05 |
Normal 180 Day Track No User Fee |
| S150 |
2022-11-14 |
30-day Notice |
| S149 |
2022-10-25 |
30-day Notice |
| S148 |
2022-10-04 |
30-day Notice |
| S147 |
2022-09-26 |
30-day Notice |
| S146 | | |
| S145 |
2022-08-25 |
Normal 180 Day Track No User Fee |
| S144 |
2022-08-25 |
30-day Notice |
| S143 | | |
| S142 | | |
| S141 |
2022-05-02 |
Normal 180 Day Track |
| S140 | | |
| S139 |
2022-01-14 |
30-day Notice |
| S138 |
2021-11-03 |
Normal 180 Day Track No User Fee |
| S137 |
2021-10-19 |
30-day Notice |
| S136 |
2021-09-30 |
30-day Notice |
| S135 |
2021-09-27 |
30-day Notice |
| S134 |
2021-08-30 |
30-day Notice |
| S133 |
2021-08-25 |
30-day Notice |
| S132 |
2021-08-04 |
30-day Notice |
| S131 |
2021-07-20 |
Real-time Process |
| S130 | | |
| S129 |
2021-06-25 |
30-day Notice |
| S128 |
2021-03-02 |
30-day Notice |
| S127 |
2021-02-22 |
30-day Notice |
| S126 |
2020-11-20 |
Real-time Process |
| S125 | | |
| S124 |
2020-11-17 |
30-day Notice |
| S123 |
2020-11-16 |
30-day Notice |
| S122 |
2020-11-02 |
30-day Notice |
| S121 |
2020-10-28 |
30-day Notice |
| S120 |
2020-09-21 |
30-day Notice |
| S119 |
2020-09-08 |
30-day Notice |
| S118 |
2020-08-10 |
30-day Notice |
| S117 |
2020-06-26 |
30-day Notice |
| S116 | | |
| S115 |
2020-04-30 |
30-day Notice |
| S114 |
2020-04-03 |
30-day Notice |
| S113 |
2020-04-01 |
30-day Notice |
| S112 | | |
| S111 |
2020-03-12 |
30-day Notice |
| S110 |
2020-02-10 |
30-day Notice |
| S109 |
2020-02-07 |
30-day Notice |
| S108 |
2020-02-04 |
30-day Notice |
| S107 | | |
| S106 | | |
| S105 |
2020-01-10 |
30-day Notice |
| S104 | | |
| S103 | | |
| S102 | | |
| S101 |
2019-11-18 |
30-day Notice |
| S100 |
2019-11-01 |
30-day Notice |
| S099 | | |
| S098 |
2019-10-18 |
30-day Notice |
| S097 |
2019-09-27 |
30-day Notice |
| S096 |
2019-09-16 |
30-day Notice |
| S095 |
2019-09-13 |
30-day Notice |
| S094 |
2019-08-30 |
Special (immediate Track) |
| S093 | | |
| S092 | | |
| S091 |
2019-07-22 |
Real-time Process |
| S090 |
2019-07-16 |
Special (immediate Track) |
| S089 |
2019-05-31 |
30-day Notice |
| S088 |
2019-05-28 |
Real-time Process |
| S087 |
2019-05-17 |
Normal 180 Day Track |
| S086 | | |
| S085 |
2019-04-01 |
Panel Track |
| S084 |
2019-02-22 |
Special (immediate Track) |
| S083 |
2019-02-21 |
30-day Notice |
| S082 |
2019-02-19 |
30-day Notice |
| S081 |
2019-02-08 |
30-day Notice |
| S080 |
2019-01-31 |
30-day Notice |
| S079 |
2018-11-14 |
30-day Notice |
| S078 |
2018-11-09 |
30-day Notice |
| S077 |
2018-10-31 |
30-day Notice |
| S076 |
2018-10-23 |
30-day Notice |
| S075 |
2018-10-18 |
30-day Notice |
| S074 |
2018-09-18 |
Normal 180 Day Track |
| S073 |
2018-08-20 |
30-day Notice |
| S072 |
2018-08-09 |
30-day Notice |
| S071 |
2018-07-11 |
30-day Notice |
| S070 |
2018-07-09 |
30-day Notice |
| S069 |
2018-07-02 |
30-day Notice |
| S068 |
2018-06-28 |
30-day Notice |
| S067 |
2018-05-29 |
Normal 180 Day Track No User Fee |
| S066 |
2018-05-25 |
30-day Notice |
| S065 |
2018-04-23 |
30-day Notice |
| S064 |
2018-04-13 |
Normal 180 Day Track |
| S063 |
2018-03-26 |
30-day Notice |
| S062 |
2018-03-13 |
30-day Notice |
| S061 |
2018-03-05 |
30-day Notice |
| S060 |
2018-03-01 |
30-day Notice |
| S059 |
2018-02-02 |
30-day Notice |
| S058 |
2017-11-20 |
30-day Notice |
| S057 |
2017-11-20 |
30-day Notice |
| S056 |
2017-11-06 |
30-day Notice |
| S055 |
2017-10-31 |
30-day Notice |
| S054 |
2017-09-25 |
30-day Notice |
| S053 |
2017-09-08 |
30-day Notice |
| S052 |
2017-08-23 |
Normal 180 Day Track |
| S051 |
2017-07-03 |
30-day Notice |
| S050 |
2017-06-30 |
30-day Notice |
| S049 |
2017-06-27 |
30-day Notice |
| S048 |
2017-06-22 |
Normal 180 Day Track No User Fee |
| S047 |
2017-06-22 |
Normal 180 Day Track No User Fee |
| S046 |
2017-06-22 |
30-day Notice |
| S045 |
2017-06-19 |
30-day Notice |
| S044 |
2017-06-01 |
30-day Notice |
| S043 |
2017-05-25 |
30-day Notice |
| S042 |
2017-05-24 |
30-day Notice |
| S041 |
2017-04-27 |
Real-time Process |
| S040 | | |
| S039 |
2017-04-25 |
30-day Notice |
| S038 |
2017-04-10 |
30-day Notice |
| S037 |
2017-03-24 |
30-day Notice |
| S036 |
2017-03-23 |
30-day Notice |
| S035 |
2017-03-23 |
Real-time Process |
| S034 |
2017-03-16 |
Real-time Process |
| S033 |
2017-03-13 |
Special (immediate Track) |
| S032 |
2017-02-13 |
30-day Notice |
| S031 |
2017-01-31 |
30-day Notice |
| S030 |
2017-01-30 |
30-day Notice |
| S029 |
2017-01-11 |
30-day Notice |
| S028 |
2016-12-09 |
Panel Track |
| S027 |
2016-11-18 |
30-day Notice |
| S026 |
2016-11-17 |
30-day Notice |
| S025 |
2016-11-15 |
135 Review Track For 30-day Notice |
| S024 |
2016-08-30 |
Normal 180 Day Track |
| S023 |
2016-08-29 |
30-day Notice |
| S022 |
2016-08-22 |
30-day Notice |
| S021 |
2016-08-12 |
30-day Notice |
| S020 |
2016-08-10 |
30-day Notice |
| S019 |
2016-08-08 |
30-day Notice |
| S018 |
2016-06-06 |
Normal 180 Day Track No User Fee |
| S017 |
2016-05-25 |
30-day Notice |
| S016 |
2016-05-16 |
Special (immediate Track) |
| S015 |
2016-04-22 |
Normal 180 Day Track No User Fee |
| S014 | | |
| S013 |
2016-04-12 |
30-day Notice |
| S012 |
2016-03-16 |
30-day Notice |
| S011 |
2016-03-01 |
30-day Notice |
| S010 |
2016-02-29 |
Panel Track |
| S009 |
2016-02-18 |
30-day Notice |
| S008 |
2016-02-05 |
30-day Notice |
| S007 |
2016-02-08 |
Real-time Process |
| S006 |
2016-01-15 |
30-day Notice |
| S005 |
2015-12-18 |
30-day Notice |
| S004 |
2015-12-16 |
30-day Notice |
| S003 |
2015-10-07 |
Normal 180 Day Track |
| S002 |
2015-08-19 |
Normal 180 Day Track No User Fee |
| S001 |
2015-07-27 |
30-day Notice |
NIH GUDID Devices