Modifications to the solutions mixing clean room in the singapore facility
| Device | Edwards SAPIEN XT Transcatheter Heart Valve |
| Generic Name | Aortic Valve, Prosthesis, Percutaneously Delivered |
| Applicant | EDWARDS LIFESCIENCES, LLC. |
| Date Received | 2020-10-28 |
| Decision Date | 2020-11-10 |
| PMA | P130009 |
| Supplement | S112 |
| 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 |
|---|
| P130009 | | Original Filing |
| S113 |
2021-02-22 |
30-day Notice |
| S112 |
2020-10-28 |
30-day Notice |
| S111 |
2020-08-10 |
30-day Notice |
| S110 |
2020-06-26 |
30-day Notice |
| S109 | | |
| S108 |
2020-02-07 |
30-day Notice |
| S107 | | |
| S106 | | |
| S105 | | |
| S104 |
2019-11-01 |
30-day Notice |
| S103 |
2019-10-18 |
30-day Notice |
| S102 |
2019-09-27 |
30-day Notice |
| S101 | | |
| S100 |
2019-08-30 |
Special (immediate Track) |
| S099 | | |
| S098 | | |
| S097 |
2019-02-21 |
30-day Notice |
| S096 |
2019-01-31 |
30-day Notice |
| S095 |
2018-11-14 |
30-day Notice |
| S094 |
2018-10-31 |
30-day Notice |
| S093 |
2018-08-09 |
30-day Notice |
| S092 |
2018-07-09 |
30-day Notice |
| S091 |
2018-06-28 |
30-day Notice |
| S090 |
2018-05-25 |
30-day Notice |
| S089 |
2018-04-23 |
30-day Notice |
| S088 |
2018-03-26 |
30-day Notice |
| S087 |
2018-03-13 |
30-day Notice |
| S086 |
2018-03-05 |
30-day Notice |
| S085 |
2018-03-01 |
30-day Notice |
| S084 |
2018-02-02 |
30-day Notice |
| S083 |
2017-10-31 |
30-day Notice |
| S082 |
2017-09-11 |
30-day Notice |
| S081 |
2017-06-30 |
30-day Notice |
| S080 |
2017-06-27 |
30-day Notice |
| S079 |
2017-06-22 |
30-day Notice |
| S078 |
2017-06-19 |
30-day Notice |
| S077 |
2017-05-25 |
30-day Notice |
| S076 |
2017-05-24 |
30-day Notice |
| S075 | | |
| S074 |
2017-04-25 |
30-day Notice |
| S073 |
2017-04-10 |
30-day Notice |
| S072 |
2017-03-24 |
30-day Notice |
| S071 |
2017-03-23 |
30-day Notice |
| S070 |
2017-02-13 |
30-day Notice |
| S069 |
2017-01-11 |
30-day Notice |
| S068 |
2016-11-16 |
Normal 180 Day Track No User Fee |
| S067 |
2016-11-17 |
30-day Notice |
| S066 |
2016-11-15 |
135 Review Track For 30-day Notice |
| S065 |
2016-10-11 |
30-day Notice |
| S064 |
2016-08-22 |
30-day Notice |
| S063 |
2016-07-05 |
30-day Notice |
| S062 |
2016-07-01 |
Normal 180 Day Track No User Fee |
| S061 |
2016-06-30 |
Normal 180 Day Track No User Fee |
| S060 |
2016-06-02 |
Special (immediate Track) |
| S059 |
2016-05-25 |
30-day Notice |
| S058 |
2016-05-16 |
Special (immediate Track) |
| S057 |
2016-05-02 |
Panel Track |
| S056 | | |
| S055 |
2016-04-12 |
30-day Notice |
| S054 |
2016-03-28 |
Special (immediate Track) |
| S053 |
2016-03-23 |
Normal 180 Day Track No User Fee |
| S052 |
2016-03-18 |
30-day Notice |
| S051 |
2016-03-01 |
30-day Notice |
| S050 |
2016-02-18 |
30-day Notice |
| S049 |
2016-02-17 |
30-day Notice |
| S048 |
2016-02-05 |
30-day Notice |
| S047 |
2016-01-20 |
Special (immediate Track) |
| S046 |
2016-01-19 |
Special (immediate Track) |
| S045 |
2016-01-15 |
30-day Notice |
| S044 |
2015-12-14 |
30-day Notice |
| S043 |
2015-12-07 |
30-day Notice |
| S042 |
2015-11-23 |
30-day Notice |
| S041 |
2015-09-30 |
30-day Notice |
| S040 |
2015-07-27 |
30-day Notice |
| S039 |
2015-07-24 |
30-day Notice |
| S038 |
2015-07-10 |
Real-time Process |
| S037 |
2015-07-01 |
Panel Track |
| S036 |
2015-05-22 |
30-day Notice |
| S035 |
2015-05-18 |
30-day Notice |
| S034 |
2015-04-15 |
Panel Track |
| S033 | | |
| S032 |
2015-03-17 |
30-day Notice |
| S031 |
2015-03-17 |
30-day Notice |
| S030 | | |
| S029 |
2015-02-18 |
30-day Notice |
| S028 |
2015-02-09 |
135 Review Track For 30-day Notice |
| S027 |
2015-02-02 |
30-day Notice |
| S026 |
2015-01-30 |
30-day Notice |
| S025 |
2015-01-28 |
30-day Notice |
| S024 |
2015-01-13 |
30-day Notice |
| S023 |
2015-01-09 |
30-day Notice |
| S022 |
2015-01-08 |
30-day Notice |
| S021 | | |
| S020 | | |
| S019 |
2014-12-03 |
30-day Notice |
| S018 |
2014-11-17 |
30-day Notice |
| S017 |
2014-11-14 |
30-day Notice |
| S016 |
2014-11-13 |
135 Review Track For 30-day Notice |
| S015 |
2014-10-17 |
30-day Notice |
| S014 |
2014-10-10 |
30-day Notice |
| S013 |
2014-10-07 |
30-day Notice |
| S012 |
2014-09-22 |
30-day Notice |
| S011 |
2014-09-04 |
30-day Notice |
| S010 |
2014-09-03 |
30-day Notice |
| S009 |
2014-09-02 |
30-day Notice |
| S008 | | |
| S007 | | |
| S006 | | |
| S005 |
2014-07-21 |
30-day Notice |
| S004 |
2014-07-17 |
135 Review Track For 30-day Notice |
| S003 |
2014-07-15 |
30-day Notice |
| S002 |
2014-07-14 |
Normal 180 Day Track No User Fee |
| S001 |
2014-07-18 |
30-day Notice |
NIH GUDID Devices