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.
To use an alternate ethylene oxide (eo) sterilization cycle at a previously approved sterilization site for the crimper model 9600cr
| Device | Sapien 3 Transcatheter Heart Valve and Accessories |
| Generic Name | Aortic Valve, Prosthesis, Percutaneously Delivered |
| Applicant | EDWARDS LIFESCIENCES, LLC. |
| Date Received | 2020-02-04 |
| Decision Date | 2020-03-05 |
| PMA | P140031 |
| Supplement | S108 |
| 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 |
| 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 |