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 | Micra AV TPS, Micra TPS |
| Generic Name | Leadless Pacemaker |
| Applicant | MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP150033 Supplement NumberS137 Date Received04/22/2022 Decision Date04/26/2022 Product Code PNJ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-04-22 |
| Decision Date | 2022-04-26 |
| PMA | P150033 |
| Supplement | S137 |
| Product Code | PNJ |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | MEDTRONIC Inc. 8200 Coral Sea Street Ne ms Mv S11 mounds View, MN 55112 PMA NumberP150033 Supplement NumberS137 Date Received04/22/2022 Decision Date04/26/2022 Product Code PNJ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement to Implement Minor Updates In The Manufacturing Of Hybrids At Medtronic Tempe Campus |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P150033 | Original Filing | |
| S164 | 2022-12-06 | 30-day Notice |
| S163 | 2022-11-21 | 30-day Notice |
| S162 | ||
| S161 | ||
| S160 | 2022-11-04 | 30-day Notice |
| S159 | ||
| S158 | ||
| S157 | 2022-10-31 | 30-day Notice |
| S156 | 2022-10-24 | 30-day Notice |
| S155 | 2022-10-03 | 30-day Notice |
| S154 | 2022-09-26 | 30-day Notice |
| S153 | ||
| S152 | 2022-09-15 | 30-day Notice |
| S151 | 2022-09-13 | 30-day Notice |
| S150 | 2022-09-01 | 30-day Notice |
| S149 | 2022-08-09 | 30-day Notice |
| S148 | 2022-07-22 | 30-day Notice |
| S147 | 2022-07-21 | 30-day Notice |
| S146 | 2022-07-21 | 30-day Notice |
| S145 | ||
| S144 | 2022-07-12 | 30-day Notice |
| S143 | 2022-06-28 | 30-day Notice |
| S142 | 2022-06-10 | 30-day Notice |
| S141 | 2022-05-20 | 30-day Notice |
| S140 | 2022-05-11 | 30-day Notice |
| S139 | ||
| S138 | 2022-04-27 | 30-day Notice |
| S137 | 2022-04-22 | 30-day Notice |
| S136 | 2022-04-14 | 30-day Notice |
| S135 | 2022-02-24 | 30-day Notice |
| S134 | 2022-01-28 | 30-day Notice |
| S133 | 2022-01-14 | 30-day Notice |
| S132 | 2022-01-13 | 30-day Notice |
| S131 | 2022-01-13 | 30-day Notice |
| S130 | 2022-01-10 | 30-day Notice |
| S129 | 2021-11-30 | 30-day Notice |
| S128 | 2021-11-19 | 30-day Notice |
| S127 | ||
| S126 | 2021-11-10 | 30-day Notice |
| S125 | 2021-10-12 | 30-day Notice |
| S124 | 2021-10-05 | 30-day Notice |
| S123 | 2021-10-04 | 30-day Notice |
| S122 | 2021-10-01 | 30-day Notice |
| S121 | ||
| S120 | 2021-09-22 | 30-day Notice |
| S119 | 2021-09-22 | 30-day Notice |
| S118 | 2021-09-08 | 30-day Notice |
| S117 | ||
| S116 | 2021-07-09 | 30-day Notice |
| S115 | 2021-07-09 | 30-day Notice |
| S114 | 2021-07-08 | 30-day Notice |
| S113 | 2021-07-01 | 30-day Notice |
| S112 | 2021-06-23 | 30-day Notice |
| S111 | 2021-06-21 | 30-day Notice |
| S110 | 2021-06-11 | 30-day Notice |
| S109 | 2021-05-27 | 30-day Notice |
| S108 | ||
| S107 | ||
| S106 | 2021-04-27 | 30-day Notice |
| S105 | 2021-04-23 | Special (immediate Track) |
| S104 | ||
| S103 | 2021-03-26 | 30-day Notice |
| S102 | ||
| S101 | ||
| S100 | ||
| S099 | 2021-03-16 | 30-day Notice |
| S098 | ||
| S097 | 2021-03-09 | 30-day Notice |
| S096 | ||
| S095 | ||
| S094 | 2021-02-09 | 30-day Notice |
| S093 | ||
| S092 | 2021-01-21 | 30-day Notice |
| S091 | 2020-11-24 | 30-day Notice |
| S090 | ||
| S089 | 2020-11-19 | 30-day Notice |
| S088 | ||
| S087 | 2020-10-23 | 30-day Notice |
| S086 | 2020-09-23 | 30-day Notice |
| S085 | ||
| S084 | 2020-07-30 | 30-day Notice |
| S083 | 2020-07-27 | 30-day Notice |
| S082 | 2020-07-14 | 30-day Notice |
| S081 | 2020-07-13 | 30-day Notice |
| S080 | 2020-07-10 | 30-day Notice |
| S079 | 2020-07-09 | 30-day Notice |
| S078 | 2020-07-02 | Normal 180 Day Track No User Fee |
| S077 | ||
| S076 | 2020-06-26 | 30-day Notice |
| S075 | 2020-05-29 | Real-time Process |
| S074 | 2020-05-15 | 30-day Notice |
| S073 | 2020-05-11 | 30-day Notice |
| S072 | 2020-04-28 | 30-day Notice |
| S071 | 2020-04-09 | 30-day Notice |
| S070 | ||
| S069 | 2020-03-30 | 30-day Notice |
| S068 | 2020-03-12 | 30-day Notice |
| S067 | ||
| S066 | 2020-02-20 | 30-day Notice |
| S065 | 2019-12-23 | Real-time Process |
| S064 | 2019-12-11 | 30-day Notice |
| S063 | 2019-11-18 | 30-day Notice |
| S062 | ||
| S061 | ||
| S060 | 2019-10-24 | 30-day Notice |
| S059 | 2019-09-27 | Real-time Process |
| S058 | 2019-09-17 | 30-day Notice |
| S057 | 2019-09-16 | 30-day Notice |
| S056 | 2019-09-16 | 30-day Notice |
| S055 | 2019-06-10 | 30-day Notice |
| S054 | 2019-04-11 | 30-day Notice |
| S053 | 2019-03-28 | 30-day Notice |
| S052 | ||
| S051 | ||
| S050 | ||
| S049 | 2019-02-26 | 30-day Notice |
| S048 | 2019-01-23 | 30-day Notice |
| S047 | 2018-11-27 | 30-day Notice |
| S046 | 2018-10-23 | 30-day Notice |
| S045 | 2018-10-18 | 30-day Notice |
| S044 | 2018-10-15 | 30-day Notice |
| S043 | 2018-10-09 | 30-day Notice |
| S042 | 2018-09-26 | 30-day Notice |
| S041 | 2018-08-22 | Real-time Process |
| S040 | 2018-08-08 | 30-day Notice |
| S039 | 2018-06-28 | Normal 180 Day Track No User Fee |
| S038 | 2018-07-06 | Real-time Process |
| S037 | ||
| S036 | 2018-04-17 | Real-time Process |
| S035 | 2018-04-12 | 30-day Notice |
| S034 | 2018-04-09 | 30-day Notice |
| S033 | 2018-03-12 | 30-day Notice |
| S032 | 2018-02-01 | Real-time Process |
| S031 | 2018-01-30 | 30-day Notice |
| S030 | 2018-01-17 | 30-day Notice |
| S029 | 2017-12-22 | 30-day Notice |
| S028 | 2017-11-20 | 30-day Notice |
| S027 | 2017-09-05 | Real-time Process |
| S026 | 2017-07-28 | 30-day Notice |
| S025 | 2017-06-23 | 30-day Notice |
| S024 | 2017-06-09 | 30-day Notice |
| S023 | 2017-05-12 | 30-day Notice |
| S022 | 2017-03-31 | 30-day Notice |
| S021 | 2017-03-29 | 30-day Notice |
| S020 | 2017-03-13 | Real-time Process |
| S019 | 2017-03-03 | 30-day Notice |
| S018 | 2017-02-21 | Real-time Process |
| S017 | 2017-02-17 | 30-day Notice |
| S016 | 2017-02-02 | 30-day Notice |
| S015 | 2017-02-01 | Normal 180 Day Track |
| S014 | 2017-01-13 | 30-day Notice |
| S013 | 2016-11-23 | Real-time Process |
| S012 | 2016-11-16 | Normal 180 Day Track |
| S011 | 2016-11-14 | 30-day Notice |
| S010 | 2016-10-07 | 30-day Notice |
| S009 | 2016-09-30 | Real-time Process |
| S008 | 2016-09-29 | 30-day Notice |
| S007 | 2016-09-26 | 30-day Notice |
| S006 | 2016-07-22 | 30-day Notice |
| S005 | 2016-07-22 | 30-day Notice |
| S004 | 2016-07-01 | 30-day Notice |
| S003 | 2016-05-23 | Real-time Process |
| S002 | 2016-05-06 | Real-time Process |
| S001 | 2016-04-29 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 00643169529748 | P150033 | 000 |
| 00643169711761 | P150033 | 015 |
| 00763000078621 | P150033 | 061 |
| 00763000078683 | P150033 | 161 |
| 00763000078645 | P150033 | 161 |