Approval for the edwards sapien 3 transcatheter heart valve system and edwards sapien 3 ultra transcatheter heart valve system for expanding the indication to include patients at low risk for surgical aortic valve replacement. The devices are 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 appropriate for the transcatheter heart valve replacement therapy.
| Device | SAPIEN 3 Ultra transcatheter heart valve |
| Classification Name | Aortic Valve, Prosthesis, Percutaneously Delivered |
| Generic Name | Aortic Valve, Prosthesis, Percutaneously Delivered |
| Applicant | EDWARDS LIFESCIENCES, LLC. |
| Date Received | 2019-04-01 |
| Decision Date | 2019-08-16 |
| Notice Date | 2019-08-16 |
| PMA | P140031 |
| Supplement | S085 |
| Product Code | NPT |
| Docket Number | 19m-3845 |
| Advisory Committee | Cardiovascular |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| 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 |
| Approval Order: | Approval Order |
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