Shelf life extension from 2 to 3 years
| Device | SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valves |
| Generic Name | Aortic Valve, Prosthesis, Percutaneously Delivered |
| Applicant | EDWARDS LIFESCIENCES, LLC. |
| Date Received | 2020-11-20 |
| Decision Date | 2021-02-17 |
| PMA | P140031 |
| Supplement | S126 |
| Product Code | NPT |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| 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 |
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