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.
To replace the existing recording system for monitoring parameters in the manufacturing areas and water system with an automated environmental monitoring application at the miami lakes facility
| Device | HeartWare Ventricular Assist System |
| Generic Name | Ventricular (assist) Bypass |
| Applicant | Medtronic |
| Date Received | 2020-06-19 |
| Decision Date | 2020-07-15 |
| PMA | P100047 |
| Supplement | S167 |
| 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 |
| 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 |