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.
Approval for the medtronic corevalve evolut r system and medtronic corevalve evolut pro system for expanding the indication to include patients at low risk for surgical aortic valve replacement. The devices are 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 appropriate for the transcatheter heart valve replacement therapy.
| Device | Medtronic CoreValve™ Evolut™ R System and Medtronic CoreValve™ Evolut™ Pro System |
| Classification Name | Aortic Valve, Prosthesis, Percutaneously Delivered |
| Generic Name | Aortic Valve, Prosthesis, Percutaneously Delivered |
| Applicant | MEDTRONIC COREVALVE LLC |
| Date Received | 2019-03-15 |
| Decision Date | 2019-08-16 |
| Notice Date | 2019-08-16 |
| PMA | P130021 |
| Supplement | S058 |
| Product Code | NPT |
| Docket Number | 19M-3844 |
| Advisory Committee | Cardiovascular |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDTRONIC COREVALVE LLC 3576 Unocal Place santa Rosa, CA 95403 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P130021 | Original Filing | |
| S131 | 2023-01-27 | 30-day Notice |
| S130 | ||
| S129 | 2022-11-30 | 30-day Notice |
| S128 | 2022-11-29 | 30-day Notice |
| S127 | 2022-11-18 | 30-day Notice |
| S126 | 2022-10-31 | 30-day Notice |
| S125 | 2022-10-28 | 30-day Notice |
| S124 | ||
| S123 | 2022-10-25 | 30-day Notice |
| S122 | 2022-09-12 | 30-day Notice |
| S121 | 2022-09-06 | 30-day Notice |
| S120 | ||
| S119 | 2022-07-20 | 30-day Notice |
| S118 | 2022-06-24 | 30-day Notice |
| S117 | 2022-05-31 | 30-day Notice |
| S116 | 2022-05-16 | 30-day Notice |
| S115 | ||
| S114 | 2022-03-29 | 30-day Notice |
| S113 | ||
| S112 | 2022-03-17 | 30-day Notice |
| S111 | 2022-03-15 | Special (immediate Track) |
| S110 | 2022-02-28 | 30-day Notice |
| S109 | ||
| S108 | 2022-01-26 | 30-day Notice |
| S107 | 2021-12-02 | 30-day Notice |
| S106 | 2021-11-22 | 30-day Notice |
| S105 | 2021-10-12 | 30-day Notice |
| S104 | 2021-09-22 | Special (immediate Track) |
| S103 | 2021-09-13 | 30-day Notice |
| S102 | 2021-07-22 | Normal 180 Day Track No User Fee |
| S101 | 2021-07-09 | 30-day Notice |
| S100 | 2021-07-08 | 30-day Notice |
| S099 | ||
| S098 | 2021-06-02 | 30-day Notice |
| S097 | ||
| S096 | 2021-05-18 | 30-day Notice |
| S095 | ||
| S094 | ||
| S093 | 2021-04-27 | 30-day Notice |
| S092 | ||
| S091 | 2021-04-20 | 30-day Notice |
| S090 | ||
| S089 | 2021-03-23 | 30-day Notice |
| S088 | ||
| S087 | 2021-03-04 | 30-day Notice |
| S086 | 2021-02-25 | 30-day Notice |
| S085 | 2021-02-12 | Real-time Process |
| S084 | 2021-01-05 | 30-day Notice |
| S083 | 2020-11-12 | Special (immediate Track) |
| S082 | ||
| S081 | 2020-10-26 | 30-day Notice |
| S080 | 2020-07-10 | Normal 180 Day Track No User Fee |
| S079 | 2020-07-08 | 30-day Notice |
| S078 | 2020-06-23 | 30-day Notice |
| S077 | 2020-05-22 | 30-day Notice |
| S076 | ||
| S075 | 2020-04-30 | 30-day Notice |
| S074 | 2020-04-28 | 30-day Notice |
| S073 | 2020-03-11 | Normal 180 Day Track No User Fee |
| S072 | 2020-03-04 | Real-time Process |
| S071 | 2020-02-27 | 30-day Notice |
| S070 | 2019-12-13 | 30-day Notice |
| S069 | 2019-12-09 | 30-day Notice |
| S068 | 2019-11-01 | 30-day Notice |
| S067 | 2019-10-18 | 30-day Notice |
| S066 | 2019-10-01 | 30-day Notice |
| S065 | 2019-10-01 | 30-day Notice |
| S064 | ||
| S063 | 2019-09-09 | 30-day Notice |
| S062 | 2019-08-22 | 30-day Notice |
| S061 | 2019-08-15 | 30-day Notice |
| S060 | 2019-06-04 | 30-day Notice |
| S059 | ||
| S058 | 2019-03-15 | Panel Track |
| S057 | 2018-11-21 | 30-day Notice |
| S056 | ||
| S055 | 2018-10-29 | 30-day Notice |
| S054 | 2018-09-27 | 30-day Notice |
| S053 | 2018-09-24 | 30-day Notice |
| S052 | 2018-08-10 | 30-day Notice |
| S051 | 2018-06-29 | Normal 180 Day Track |
| S050 | 2018-06-25 | 30-day Notice |
| S049 | 2017-12-21 | 30-day Notice |
| S048 | 2017-12-07 | 30-day Notice |
| S047 | 2017-11-30 | 30-day Notice |
| S046 | 2017-11-14 | 30-day Notice |
| S045 | 2017-10-18 | 30-day Notice |
| S044 | ||
| S043 | 2017-09-29 | Normal 180 Day Track |
| S042 | 2017-09-11 | 30-day Notice |
| S041 | 2017-08-04 | Normal 180 Day Track No User Fee |
| S040 | 2017-08-04 | 30-day Notice |
| S039 | 2017-07-07 | 30-day Notice |
| S038 | 2017-06-01 | 30-day Notice |
| S037 | 2017-04-10 | 30-day Notice |
| S036 | 2017-03-15 | 30-day Notice |
| S035 | 2017-03-09 | 30-day Notice |
| S034 | 2017-03-09 | Normal 180 Day Track No User Fee |
| S033 | 2017-03-06 | Panel Track |
| S032 | 2017-03-06 | 30-day Notice |
| S031 | 2017-02-21 | 135 Review Track For 30-day Notice |
| S030 | 2017-02-08 | 30-day Notice |
| S029 | 2017-02-06 | Normal 180 Day Track |
| S028 | 2017-01-13 | Normal 180 Day Track |
| S027 | 2016-11-30 | 30-day Notice |
| S026 | 2016-11-29 | Normal 180 Day Track No User Fee |
| S025 | 2016-10-13 | Normal 180 Day Track |
| S024 | 2016-08-11 | Special (immediate Track) |
| S023 | 2016-07-13 | 30-day Notice |
| S022 | 2016-06-21 | Real-time Process |
| S021 | 2016-06-16 | 30-day Notice |
| S020 | 2016-03-08 | Real-time Process |
| S019 | 2016-02-12 | 30-day Notice |
| S018 | 2015-09-21 | 135 Review Track For 30-day Notice |
| S017 | 2015-07-28 | 30-day Notice |
| S016 | 2015-07-08 | Normal 180 Day Track |
| S015 | 2015-07-06 | 30-day Notice |
| S014 | 2015-04-23 | Normal 180 Day Track |
| S013 | 2015-03-25 | Normal 180 Day Track |
| S012 | 2015-03-20 | 135 Review Track For 30-day Notice |
| S011 | 2015-03-12 | 30-day Notice |
| S010 | 2014-12-09 | Panel Track |
| S009 | 2014-11-19 | 30-day Notice |
| S008 | 2014-10-06 | Real-time Process |
| S007 | 2014-09-10 | 30-day Notice |
| S006 | 2014-08-08 | 30-day Notice |
| S005 | 2014-06-26 | Real-time Process |
| S004 | 2014-04-10 | Normal 180 Day Track |
| S003 | 2014-03-27 | Special (immediate Track) |
| S002 | 2014-02-27 | Panel Track |
| S001 |