This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
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).
| Device | SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES |
| Classification Name | Aortic Valve, Prosthesis, Percutaneously Delivered |
| Generic Name | Aortic Valve, Prosthesis, Percutaneously Delivered |
| Applicant | EDWARDS LIFESCIENCES, LLC. |
| Date Received | 2014-12-22 |
| Decision Date | 2015-06-17 |
| Notice Date | 2015-07-16 |
| PMA | P140031 |
| Supplement | S |
| Product Code | NPT |
| Docket Number | 15M-2499 |
| Advisory Committee | Cardiovascular |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | EDWARDS LIFESCIENCES, LLC. one Edwards Way irvine, CA 92614 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |