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 heartware hvad system. This device is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a bridge to cardiac transplantation (btt), myocardial recovery, or as destination therapy (dt) in patients for whom subsequent transplantation is not planned.
| Device | HeartWare™ HVAD™ System |
| Classification Name | Ventricular (assist) Bypass |
| Generic Name | Ventricular (assist) Bypass |
| Applicant | Medtronic |
| Date Received | 2017-01-31 |
| Decision Date | 2017-09-27 |
| Notice Date | 2017-10-05 |
| PMA | P100047 |
| Supplement | S090 |
| Product Code | DSQ |
| Docket Number | 17M-5968 |
| 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 8200 Coral Seast. N.e. mounds View, MN 55112 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| 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 |