Modify the parameters for the sapien 3 stent laser cutting process.
Device | SAPIEN 3 TRANSCATHETER HEART VALVE |
Classification Name | Aortic Valve, Prosthesis, Percutaneously Delivered |
Generic Name | Aortic Valve, Prosthesis, Percutaneously Delivered |
Applicant | EDWARDS LIFESCIENCES, LLC. |
Date Received | 2016-11-18 |
Decision Date | 2016-12-14 |
PMA | P140031 |
Supplement | S027 |
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 |
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