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 | Edwards SAPIEN 3 Transcatheter Heart Valve System and Accessories |
| Generic Name | Aortic Valve, Prosthesis, Percutaneously Delivered |
| Applicant | EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP140031 Supplement NumberS149 Date Received10/25/2022 Decision Date11/16/2022 Product Code NPT Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-10-25 |
| Decision Date | 2022-11-16 |
| PMA | P140031 |
| Supplement | S149 |
| Product Code | NPT |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | EDWARDS LIFESCIENCES, LLC. one Edwards Way irvine, CA 92614 PMA NumberP140031 Supplement NumberS149 Date Received10/25/2022 Decision Date11/16/2022 Product Code NPT Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement a Modification To The In-process Acceptance Criteria And Inspection Method For Tissue Separations On The Leaflet Free Edge Of The SAPIEN 3, SAPIEN 3 Ultra, And SAPIEN 3 Ultra RESILIA Transcatheter Heart Valves |
| 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 |