This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) System |
| Generic Name | Aortic Valve, Prosthesis, Percutaneously Delivered |
| Applicant | EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP140031 Supplement NumberS145 Date Received08/25/2022 Decision Date09/23/2022 Product Code NPT Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No |
| Date Received | 2022-08-25 |
| Decision Date | 2022-09-23 |
| PMA | P140031 |
| Supplement | S145 |
| Product Code | NPT |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | EDWARDS LIFESCIENCES, LLC. one Edwards Way irvine, CA 92614 PMA NumberP140031 Supplement NumberS145 Date Received08/25/2022 Decision Date09/23/2022 Product Code NPT Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval Of The Protocol For The Post-approval Study (PAS) Outlined In The Approval Order For P140031/S141. |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00690103193978 | P140031 | 000 |
| 00690103193930 | P140031 | 000 |
| 00690103193947 | P140031 | 000 |
| 00690103193954 | P140031 | 000 |
| 00690103193961 | P140031 | 000 |
| 00690103194364 | P140031 | 000 |
| 00690103194005 | P140031 | 000 |
| 00690103194340 | P140031 | 000 |
| 00690103194357 | P140031 | 000 |
| 00690103194166 | P140031 | 024 |
| 00690103194173 | P140031 | 024 |
| 00690103194159 | P140031 | 024 |
| 00690103194142 | P140031 | 024 |
| 00690103194135 | P140031 | 024 |
| 00690103194180 | P140031 | 024 |
| 00690103198331 | P140031 | 035 |
| 00690103201451 | P140031 | 074 |
| 00690103200782 | P140031 | 074 |
| 00690103201444 | P140031 | 074 |
| 00690103201338 | P140031 | 074 |
| 00690103201321 | P140031 | 074 |
| 00690103201314 | P140031 | 074 |
| 00690103201260 | P140031 | 074 |
| 00690103201253 | P140031 | 074 |
| 00690103201246 | P140031 | 074 |
| 00690103201239 | P140031 | 074 |
| 00690103201192 | P140031 | 074 |
| 00690103201185 | P140031 | 074 |
| 00690103207811 | P140031 | 091 |
| 00690103207828 | P140031 | 091 |
| 00690103207835 | P140031 | 091 |
| 00690103217001 | P140031 | 141 |
| 00690103215823 | P140031 | 141 |
| 00690103215816 | P140031 | 141 |
| 00690103215809 | P140031 | 141 |
| 00690103215793 | P140031 | 141 |