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.
An increase to the established action limits used in the bioburden monitoring process and the establishment of new alert limits
| Device | EnVeo R, EnVeo PRO, Evolut PRO+ Delivery Catheter Systems and Loading Systems of the Evolut R, PRO and PRO+ Systems |
| Generic Name | Aortic Valve, Prosthesis, Percutaneously Delivered |
| Applicant | MEDTRONIC COREVALVE LLC |
| Date Received | 2020-04-28 |
| Decision Date | 2020-05-01 |
| PMA | P130021 |
| Supplement | S074 |
| 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 | MEDTRONIC COREVALVE LLC 3576 Unocal Place santa Rosa, CA 95403 |
| 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 |