Approval for the micra transcatheter pacemaker system (pacemaker model mc1vr01 and programmer application software model sw022 version 1. 1). This device is indicated for use in patients who have experienced one or more of the following conditions:• symptomatic paroxysmal or permanent high-grade av block in the presence of af• symptomatic paroxysmal or permanent high-grade av block in the absence of af, as an alternative to dual chamber pacing, when atrial lead placement is considered difficult, high risk, or not deemed necessary for effective therapy• symptomatic bradycardia-tachycardia syndrome or sinus node dysfunction (sinus bradycardia or sinus pauses), as an alternative to atrial or dual chamber pacing, when atrial lead placement is considered difficult, high risk, or not deemed necessary for effective therapyrate-responsive pacing is indicated to provide increased heart rate appropriate to increasing levels of activity.
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