This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the heartware ventricular assist system (vas). This device is indicated for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The heart ware vas is designed for in-hospital and out-of-hospital settings, including transportation via fixed wing aircraft or helicopter.
| Device | HEARTWARE VENTRICULAR ASSIST SYSTEM |
| Classification Name | Ventricular (assist) Bypass |
| Generic Name | Ventricular (assist) Bypass |
| Applicant | Medtronic |
| Date Received | 2010-12-28 |
| Decision Date | 2012-11-20 |
| Notice Date | 2012-12-05 |
| PMA | P100047 |
| Supplement | S |
| Product Code | DSQ |
| Docket Number | 12M-1184 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Medtronic 8200 Coral Seast. N.e. mounds View, MN 55112 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P100047 | Original Filing | |
| S205 | 2023-01-19 | 30-day Notice |
| S204 | ||
| S203 | ||
| S202 | 2022-10-03 | 30-day Notice |
| S201 | 2022-05-31 | 30-day Notice |
| S200 | ||
| S199 | 2022-05-25 | 30-day Notice |
| S198 | 2022-05-24 | 30-day Notice |
| S197 | 2022-04-18 | 30-day Notice |
| S196 | ||
| S195 | 2022-02-15 | Special (immediate Track) |
| S194 | 2022-02-15 | 30-day Notice |
| S193 | 2022-02-14 | Special (immediate Track) |
| S192 | 2022-02-08 | 30-day Notice |
| S191 | 2021-10-28 | 30-day Notice |
| S190 | 2021-09-23 | 30-day Notice |
| S189 | 2021-07-19 | Real-time Process |
| S188 | 2021-07-14 | 30-day Notice |
| S187 | ||
| S186 | 2021-07-09 | 30-day Notice |
| S185 | 2021-06-24 | 30-day Notice |
| S184 | ||
| S183 | ||
| S182 | 2021-06-01 | 30-day Notice |
| S181 | 2021-05-28 | 30-day Notice |
| S180 | 2021-05-24 | Special (immediate Track) |
| S179 | 2021-04-27 | 30-day Notice |
| S178 | ||
| S177 | ||
| S176 | 2021-03-01 | Special (immediate Track) |
| S175 | 2021-02-10 | 30-day Notice |
| S174 | ||
| S173 | ||
| S172 | 2020-09-15 | 30-day Notice |
| S171 | 2020-08-31 | 30-day Notice |
| S170 | 2020-08-07 | 30-day Notice |
| S169 | ||
| S168 | 2020-06-29 | 30-day Notice |
| S167 | 2020-06-19 | 30-day Notice |
| S166 | ||
| S165 | ||
| S164 | 2020-05-26 | 30-day Notice |
| S163 | ||
| S162 | 2020-05-07 | 30-day Notice |
| S161 | 2020-04-10 | 30-day Notice |
| S160 | ||
| S159 | ||
| S158 | 2020-03-13 | 30-day Notice |
| S157 | 2020-03-09 | 30-day Notice |
| S156 | 2020-03-05 | 30-day Notice |
| S155 | ||
| S154 | 2020-02-12 | Real-time Process |
| S153 | 2020-02-04 | 30-day Notice |
| S152 | 2020-01-27 | 30-day Notice |
| S151 | ||
| S150 | 2019-11-18 | 135 Review Track For 30-day Notice |
| S149 | ||
| S148 | 2019-09-27 | 30-day Notice |
| S147 | 2019-09-25 | 30-day Notice |
| S146 | ||
| S145 | 2019-08-08 | 30-day Notice |
| S144 | ||
| S143 | 2019-07-26 | 30-day Notice |
| S142 | ||
| S141 | 2019-06-10 | 30-day Notice |
| S140 | 2019-05-31 | 30-day Notice |
| S139 | ||
| S138 | ||
| S137 | 2019-03-04 | 30-day Notice |
| S136 | 2019-02-27 | 30-day Notice |
| S135 | 2019-02-19 | Special (immediate Track) |
| S134 | ||
| S133 | 2018-12-17 | Normal 180 Day Track No User Fee |
| S132 | ||
| S131 | ||
| S130 | 2018-09-24 | 30-day Notice |
| S129 | ||
| S128 | ||
| S127 | 2018-08-24 | 30-day Notice |
| S126 | 2018-07-13 | 30-day Notice |
| S125 | 2018-06-14 | 30-day Notice |
| S124 | 2018-06-08 | Normal 180 Day Track No User Fee |
| S123 | 2018-05-31 | 30-day Notice |
| S122 | 2018-05-10 | Real-time Process |
| S121 | 2018-05-07 | 30-day Notice |
| S120 | 2018-05-02 | 135 Review Track For 30-day Notice |
| S119 | 2018-04-10 | 30-day Notice |
| S118 | 2018-03-15 | Special (immediate Track) |
| S117 | 2018-01-29 | 30-day Notice |
| S116 | 2017-10-31 | 30-day Notice |
| S115 | 2017-10-30 | Normal 180 Day Track No User Fee |
| S114 | 2017-10-30 | Normal 180 Day Track No User Fee |
| S113 | 2017-10-26 | 30-day Notice |
| S112 | 2017-10-10 | Normal 180 Day Track |
| S111 | 2017-09-28 | Normal 180 Day Track |
| S110 | 2017-09-25 | Normal 180 Day Track |
| S109 | 2017-08-28 | 30-day Notice |
| S108 | 2017-08-16 | 30-day Notice |
| S107 | 2017-08-14 | 30-day Notice |
| S106 | 2017-07-31 | 30-day Notice |
| S105 | 2017-07-27 | 30-day Notice |
| S104 | 2017-07-27 | 30-day Notice |
| S103 | 2017-07-20 | 30-day Notice |
| S102 | 2017-07-17 | 30-day Notice |
| S101 | 2017-06-20 | Normal 180 Day Track |
| S100 | 2017-06-06 | 30-day Notice |
| S099 | 2017-06-05 | 30-day Notice |
| S098 | 2017-06-05 | 30-day Notice |
| S097 | 2017-05-30 | 30-day Notice |
| S096 | 2017-05-30 | 30-day Notice |
| S095 | 2017-05-30 | 30-day Notice |
| S094 | 2017-05-24 | 30-day Notice |
| S093 | 2017-05-22 | 30-day Notice |
| S092 | 2017-05-15 | 30-day Notice |
| S091 | 2017-02-14 | 30-day Notice |
| S090 | 2017-01-31 | Panel Track |
| S089 | 2016-11-21 | 135 Review Track For 30-day Notice |
| S088 | 2016-11-18 | 30-day Notice |
| S087 | 2016-11-17 | 30-day Notice |
| S086 | 2016-10-31 | 30-day Notice |
| S085 | 2016-10-06 | 30-day Notice |
| S084 | 2016-10-05 | 30-day Notice |
| S083 | 2016-08-22 | 30-day Notice |
| S082 | 2016-08-19 | Normal 180 Day Track |
| S081 | 2016-08-15 | 30-day Notice |
| S080 | 2016-08-11 | 30-day Notice |
| S079 | 2016-08-03 | 30-day Notice |
| S078 | 2016-07-25 | 30-day Notice |
| S077 | 2016-06-17 | Normal 180 Day Track |
| S076 | 2016-05-25 | 30-day Notice |
| S075 | 2016-05-25 | Special (immediate Track) |
| S074 | 2016-04-19 | 30-day Notice |
| S073 | 2016-02-22 | 30-day Notice |
| S072 | 2016-02-19 | 30-day Notice |
| S071 | 2015-12-28 | 30-day Notice |
| S070 | 2015-11-24 | 135 Review Track For 30-day Notice |
| S069 | 2015-11-20 | 30-day Notice |
| S068 | 2015-11-04 | 30-day Notice |
| S067 | 2015-10-22 | 30-day Notice |
| S066 | 2015-10-19 | 30-day Notice |
| S065 | 2015-07-28 | 30-day Notice |
| S064 | 2015-07-27 | Normal 180 Day Track No User Fee |
| S063 | 2015-06-12 | 30-day Notice |
| S062 | 2015-06-03 | 30-day Notice |
| S061 | 2015-06-03 | 30-day Notice |
| S060 | 2015-06-03 | 30-day Notice |
| S059 | ||
| S058 | ||
| S057 | 2015-05-26 | Normal 180 Day Track |
| S056 | 2015-02-26 | 30-day Notice |
| S055 | 2015-02-23 | Special (immediate Track) |
| S054 | 2014-12-04 | 30-day Notice |
| S053 | 2014-11-13 | Normal 180 Day Track |
| S052 | 2014-11-07 | 30-day Notice |
| S051 | 2014-11-03 | 30-day Notice |
| S050 | 2014-09-17 | 30-day Notice |
| S049 | 2014-08-11 | Normal 180 Day Track |
| S048 | 2014-07-15 | 30-day Notice |
| S047 | 2014-06-16 | Real-time Process |
| S046 | 2014-05-29 | Normal 180 Day Track No User Fee |
| S045 | 2014-05-29 | Normal 180 Day Track No User Fee |
| S044 | 2014-05-29 | Special (immediate Track) |
| S043 | 2014-05-14 | 30-day Notice |
| S042 | 2014-05-13 | 30-day Notice |
| S041 | 2014-03-05 | 30-day Notice |
| S040 | 2014-02-26 | Normal 180 Day Track |
| S039 | 2014-02-12 | 30-day Notice |
| S038 | 2014-02-11 | 30-day Notice |
| S037 | 2014-02-11 | 30-day Notice |
| S036 | 2014-01-22 | 30-day Notice |
| S035 | 2014-01-14 | Normal 180 Day Track |
| S034 | 2014-01-10 | 30-day Notice |
| S033 | 2013-11-18 | Real-time Process |
| S032 | 2013-12-06 | Real-time Process |
| S031 | 2013-09-30 | 30-day Notice |
| S030 | 2013-09-17 | 30-day Notice |
| S029 | 2013-08-07 | 30-day Notice |
| S028 | 2013-07-05 | 30-day Notice |
| S027 | 2013-06-25 | 30-day Notice |
| S026 | 2013-06-17 | Normal 180 Day Track No User Fee |
| S025 | 2013-06-17 | Normal 180 Day Track No User Fee |
| S024 | 2013-06-17 | Normal 180 Day Track No User Fee |
| S023 | 2013-06-03 | Real-time Process |
| S022 | 2013-05-31 | Special (immediate Track) |
| S021 | 2013-05-13 | Normal 180 Day Track |
| S020 | 2013-05-01 | Normal 180 Day Track |
| S019 | 2013-04-01 | Real-time Process |
| S018 | 2013-03-04 | 30-day Notice |
| S017 | 2013-02-27 | 30-day Notice |
| S016 | ||
| S015 | 2013-01-23 | 30-day Notice |
| S014 | 2012-12-20 | Normal 180 Day Track No User Fee |
| S013 | 2012-12-05 | 135 Review Track For 30-day Notice |
| S012 | 2012-12-05 | 30-day Notice |
| S011 | 2012-12-05 | 30-day Notice |
| S010 | 2012-12-05 | 135 Review Track For 30-day Notice |
| S009 | 2012-12-03 | 30-day Notice |
| S008 | 2012-11-29 | 30-day Notice |
| S007 | 2012-11-30 | 30-day Notice |
| S006 | 2012-11-30 | 30-day Notice |
| S005 | 2012-11-29 | 135 Review Track For 30-day Notice |
| S004 | 2012-11-29 | 30-day Notice |
| S003 | 2012-11-27 | 30-day Notice |
| S002 | 2012-11-27 | 30-day Notice |
| S001 | 2012-11-27 | 30-day Notice |