Approval for the sapien xt transcatheter heart valve, model 9300tfx, and accessories. This device is indicated for use in patients with symptomatic heart disease due to either severe native calcific aortic stenosis or failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i. E. , society of thoracic surgeons operative risk score >8% or at a >15% risk of mortality at 30 days).
| Device | EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES |
| Classification Name | Aortic Valve, Prosthesis, Percutaneously Delivered |
| Generic Name | Aortic Valve, Prosthesis, Percutaneously Delivered |
| Applicant | EDWARDS LIFESCIENCES, LLC. |
| Date Received | 2015-04-15 |
| Decision Date | 2015-10-09 |
| Notice Date | 2015-11-03 |
| PMA | P130009 |
| Supplement | S034 |
| Product Code | NPT |
| Docket Number | 15M-4017 |
| Advisory Committee | Cardiovascular |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | EDWARDS LIFESCIENCES, LLC. one Edwards Way irvine, CA 92614 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
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