Approval for the edwards sapien xt transcatheter heart valve and accessories for expanding the indication to include patients with intermediate surgical risk for aortic valve replacement. The device is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be at intermediate or greater risk for open surgical therapy (i. E. , predicted risk of surgical mortality >= 3% at 30 days, based on the society of thoracic surgeons (sts) risk score and other clinical co-morbidities unmeasured by the sts risk calculator).
| 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 | 2016-05-02 |
| Decision Date | 2016-08-18 |
| Notice Date | 2016-08-19 |
| PMA | P130009 |
| Supplement | S057 |
| Product Code | NPT |
| Docket Number | 16M-2498 |
| Advisory Committee | Cardiovascular |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | Yes |
| 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