Approval for the tupos lv/atx crt-d, kronos lv-t crt-d, 505. U programmer software for the ics 3000, a-k00. 7. U programmer software for the epr/tms 1000plus and corox otw steroid lead. The tupos lv/atx and kronos lv-t crt-ds are indicated for use in patients with all of the following conditions: 1) indicated for icd therapy; 2) receiving optimized and stable congestive heart failure (chf) drug therapy; 3) symptomatic chf (nyha class iii/iv and lvef =130 ms). The tupos lv/atx is also indicated for patients who, in addition to an indication for a crt-d device, have atrial tachyarrhythmias or are at risk of developing atrial tachyarrhythmias. The corox otw steroid leads are intended for implantation via the coronary veins to provide long term cardiac pacing when used in conjunction with a compatible pulse generator.
| Device | TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD |
| Classification Name | Defibrillator, Implantable, Dual-chamber |
| Generic Name | Defibrillator, Implantable, Dual-chamber |
| Applicant | BIOTRONIK, INC. |
| Date Received | 2005-07-11 |
| Decision Date | 2006-08-10 |
| Notice Date | 2006-09-08 |
| PMA | P050023 |
| Supplement | S |
| Product Code | MRM |
| Docket Number | 06M-0367 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BIOTRONIK, INC. 6024 Jean Road lake Oswego, OR 97035 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
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