To implement a rework coating process and associated updates for manufacturing documentation
| Device | Micra AV TPS, Micra TPS |
| Generic Name | Leadless Pacemaker |
| Applicant | MEDTRONIC Inc. |
| Date Received | 2021-09-08 |
| Decision Date | 2021-09-15 |
| PMA | P150033 |
| Supplement | S118 |
| 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 |
Supplemental Filings
| 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 |
NIH GUDID Devices