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.
| Device | HeartWare Ventricular Assist System |
| Generic Name | Ventricular (assist) Bypass |
| Applicant | Medtronic8200 Coral Seast. N.e.mounds View, MN 55112 PMA NumberP100047 Supplement NumberS192 Date Received02/08/2022 Decision Date03/01/2022 Product Code DSQ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-02-08 |
| Decision Date | 2022-03-01 |
| PMA | P100047 |
| Supplement | S192 |
| Product Code | DSQ |
| 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 8200 Coral Seast. N.e. mounds View, MN 55112 PMA NumberP100047 Supplement NumberS192 Date Received02/08/2022 Decision Date03/01/2022 Product Code DSQ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement an Addition Of A Visual Inspection Step In Splice Kit Assembly Procedure |
| 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 |