Approval for 3. 0 tesla mr conditional labeling of edora, evity and enitra promri pacemaker and crt-p systems.
| Device | Accessory to Defibrillator, Automatic Implantable Cardioverter, with Cardiac Resynchronization (CRT-D) |
| Classification Name | Defibrillator, Implantable, Dual-chamber |
| Generic Name | Defibrillator, Implantable, Dual-chamber |
| Applicant | BIOTRONIK, INC. |
| Date Received | 2018-02-09 |
| Decision Date | 2018-12-19 |
| PMA | P050023 |
| Supplement | S116 |
| Product Code | MRM |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BIOTRONIK, INC. 6024 Jean Road lake Oswego, OR 97035 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P050023 | | Original Filing |
| S170 |
2022-11-30 |
Normal 180 Day Track No User Fee |
| S169 |
2022-11-15 |
Real-time Process |
| S168 |
2022-11-10 |
30-day Notice |
| S167 |
2022-06-17 |
30-day Notice |
| S166 |
2022-02-07 |
Real-time Process |
| S165 |
2021-12-08 |
Real-time Process |
| S164 |
2021-10-29 |
Real-time Process |
| S163 |
2021-09-30 |
30-day Notice |
| S162 | | |
| S161 | | |
| S160 |
2021-07-21 |
30-day Notice |
| S159 |
2021-07-19 |
30-day Notice |
| S158 |
2021-06-21 |
30-day Notice |
| S157 | | |
| S156 |
2021-05-05 |
30-day Notice |
| S155 |
2021-05-04 |
30-day Notice |
| S154 |
2021-03-16 |
Real-time Process |
| S153 |
2020-11-23 |
30-day Notice |
| S152 |
2020-11-02 |
30-day Notice |
| S151 | | |
| S150 |
2020-08-10 |
Real-time Process |
| S149 |
2020-07-30 |
Normal 180 Day Track No User Fee |
| S148 | | |
| S147 |
2020-04-30 |
Real-time Process |
| S146 |
2020-03-26 |
30-day Notice |
| S145 | | |
| S144 | | |
| S143 |
2020-02-11 |
30-day Notice |
| S142 | | |
| S141 |
2019-12-31 |
30-day Notice |
| S140 |
2019-11-27 |
30-day Notice |
| S139 | | |
| S138 |
2019-10-11 |
Real-time Process |
| S137 | | |
| S136 |
2019-09-17 |
30-day Notice |
| S135 |
2019-08-19 |
30-day Notice |
| S134 | | |
| S133 |
2019-07-01 |
Real-time Process |
| S132 | | |
| S131 |
2019-04-23 |
30-day Notice |
| S130 |
2019-03-11 |
Real-time Process |
| S129 |
2019-01-23 |
30-day Notice |
| S128 | | |
| S127 |
2018-11-16 |
30-day Notice |
| S126 | | |
| S125 |
2018-09-12 |
Normal 180 Day Track |
| S124 |
2018-08-22 |
Real-time Process |
| S123 |
2018-07-13 |
Normal 180 Day Track |
| S122 |
2018-07-10 |
30-day Notice |
| S121 |
2018-06-14 |
135 Review Track For 30-day Notice |
| S120 |
2018-05-18 |
30-day Notice |
| S119 |
2018-05-17 |
Real-time Process |
| S118 |
2018-03-05 |
30-day Notice |
| S117 |
2018-02-23 |
135 Review Track For 30-day Notice |
| S116 |
2018-02-09 |
Normal 180 Day Track |
| S115 |
2018-01-22 |
30-day Notice |
| S114 |
2017-11-20 |
Real-time Process |
| S113 |
2017-10-18 |
Real-time Process |
| S112 |
2017-06-06 |
Real-time Process |
| S111 |
2017-05-24 |
Real-time Process |
| S110 |
2017-05-23 |
Normal 180 Day Track No User Fee |
| S109 |
2017-05-05 |
Real-time Process |
| S108 |
2017-04-20 |
Real-time Process |
| S107 |
2017-02-16 |
Normal 180 Day Track |
| S106 |
2017-01-03 |
30-day Notice |
| S105 |
2016-12-07 |
Normal 180 Day Track |
| S104 |
2016-08-08 |
Normal 180 Day Track |
| S103 |
2016-07-28 |
Normal 180 Day Track |
| S102 |
2016-06-09 |
Real-time Process |
| S101 |
2016-06-06 |
Normal 180 Day Track |
| S100 |
2016-06-02 |
Normal 180 Day Track No User Fee |
| S099 |
2016-05-31 |
30-day Notice |
| S098 |
2016-05-12 |
Real-time Process |
| S097 |
2016-03-24 |
Real-time Process |
| S096 |
2016-03-03 |
30-day Notice |
| S095 |
2016-01-21 |
Normal 180 Day Track No User Fee |
| S094 |
2015-12-23 |
Normal 180 Day Track |
| S093 |
2015-12-16 |
Real-time Process |
| S092 |
2015-05-27 |
30-day Notice |
| S091 |
2015-05-19 |
30-day Notice |
| S090 |
2015-05-11 |
Normal 180 Day Track |
| S089 |
2015-04-29 |
135 Review Track For 30-day Notice |
| S088 |
2015-04-16 |
30-day Notice |
| S087 |
2015-04-16 |
Normal 180 Day Track |
| S086 |
2015-03-27 |
Real-time Process |
| S085 |
2015-03-23 |
Normal 180 Day Track |
| S084 |
2015-03-06 |
135 Review Track For 30-day Notice |
| S083 |
2015-02-13 |
Real-time Process |
| S082 |
2014-10-31 |
30-day Notice |
| S081 |
2014-09-25 |
Normal 180 Day Track |
| S080 |
2014-09-24 |
30-day Notice |
| S079 |
2014-08-04 |
Normal 180 Day Track |
| S078 |
2014-07-31 |
Real-time Process |
| S077 |
2014-06-23 |
Normal 180 Day Track |
| S076 |
2014-01-27 |
Normal 180 Day Track |
| S075 |
2014-01-10 |
Real-time Process |
| S074 |
2013-11-25 |
Normal 180 Day Track |
| S073 |
2013-11-12 |
Real-time Process |
| S072 |
2013-11-07 |
Real-time Process |
| S071 |
2013-11-05 |
30-day Notice |
| S070 |
2013-11-05 |
30-day Notice |
| S069 |
2013-08-15 |
Real-time Process |
| S068 |
2013-07-16 |
30-day Notice |
| S067 |
2013-06-14 |
Real-time Process |
| S066 |
2013-06-03 |
Real-time Process |
| S065 |
2013-04-29 |
30-day Notice |
| S064 |
2013-04-22 |
30-day Notice |
| S063 |
2013-04-03 |
Real-time Process |
| S062 | | |
| S061 |
2013-02-05 |
Real-time Process |
| S060 |
2013-01-14 |
30-day Notice |
| S059 |
2012-12-21 |
Real-time Process |
| S058 |
2012-12-18 |
Normal 180 Day Track |
| S057 |
2012-11-19 |
Real-time Process |
| S056 |
2012-10-12 |
Normal 180 Day Track No User Fee |
| S055 |
2012-09-07 |
30-day Notice |
| S054 |
2012-07-02 |
Real-time Process |
| S053 |
2012-03-01 |
Normal 180 Day Track |
| S052 |
2012-02-17 |
Real-time Process |
| S051 |
2012-02-06 |
30-day Notice |
| S050 |
2012-02-01 |
Real-time Process |
| S049 |
2012-01-30 |
Real-time Process |
| S048 |
2011-11-02 |
Normal 180 Day Track |
| S047 |
2011-08-22 |
Normal 180 Day Track |
| S046 |
2011-08-19 |
Normal 180 Day Track |
| S045 |
2011-04-11 |
Real-time Process |
| S044 |
2011-03-23 |
30-day Notice |
| S043 |
2010-12-23 |
30-day Notice |
| S042 | | |
| S041 |
2010-12-13 |
Real-time Process |
| S040 |
2010-11-09 |
30-day Notice |
| S039 |
2010-10-28 |
Normal 180 Day Track |
| S038 |
2010-09-30 |
Real-time Process |
| S037 |
2010-08-20 |
30-day Notice |
| S036 |
2010-07-21 |
30-day Notice |
| S035 |
2010-05-18 |
Normal 180 Day Track No User Fee |
| S034 |
2010-06-29 |
Real-time Process |
| S033 |
2010-06-08 |
Normal 180 Day Track |
| S032 |
2010-05-28 |
Normal 180 Day Track No User Fee |
| S031 |
2010-05-11 |
Real-time Process |
| S030 |
2010-04-13 |
30-day Notice |
| S029 |
2010-03-02 |
Real-time Process |
| S028 |
2009-11-25 |
Real-time Process |
| S027 |
2009-09-28 |
135 Review Track For 30-day Notice |
| S026 |
2009-09-10 |
Real-time Process |
| S025 | | |
| S024 |
2009-07-08 |
Normal 180 Day Track |
| S023 |
2009-03-23 |
Real-time Process |
| S022 |
2009-03-06 |
30-day Notice |
| S021 |
2009-02-13 |
Real-time Process |
| S020 |
2009-01-26 |
Normal 180 Day Track |
| S019 |
2008-11-17 |
Normal 180 Day Track |
| S018 |
2008-10-31 |
Real-time Process |
| S017 |
2008-09-25 |
135 Review Track For 30-day Notice |
| S016 |
2008-09-10 |
Normal 180 Day Track |
| S015 |
2008-07-03 |
135 Review Track For 30-day Notice |
| S014 |
2008-06-04 |
135 Review Track For 30-day Notice |
| S013 |
2008-05-21 |
Real-time Process |
| S012 |
2008-05-14 |
Real-time Process |
| S011 |
2008-05-14 |
Normal 180 Day Track |
| S010 |
2008-01-24 |
Real-time Process |
| S009 |
2008-01-15 |
Real-time Process |
| S008 |
2007-10-26 |
Normal 180 Day Track |
| S007 |
2007-08-13 |
Normal 180 Day Track |
| S006 |
2007-07-13 |
Normal 180 Day Track |
| S005 |
2007-06-25 |
30-day Notice |
| S004 | | |
| S003 |
2007-01-22 |
Real-time Process |
| S002 |
2006-10-03 |
Normal 180 Day Track No User Fee |
| S001 |
2006-09-11 |
Normal 180 Day Track |
NIH GUDID Devices