Approval for updating the labeling for the corox family over the wire (otw) left ventricular (lv) pacing lead to reflect the findings of the corox otw steroid lv monitoring (cosmo) post-approval study.
| Device | COROX OTW 75-UP STEROID LEAD, COROS OTW 85-UP STEROID LEAD |
| Classification Name | Drug Eluting Permanent Left Ventricular (lv) Pacemaker Electrode |
| Generic Name | Drug Eluting Permanent Left Ventricular (lv) Pacemaker Electrode |
| Applicant | BIOTRONIK, INC. |
| Date Received | 2012-10-12 |
| Decision Date | 2013-01-11 |
| PMA | P050023 |
| Supplement | S056 |
| Product Code | OJX |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Pas |
| Expedited Review | No |
| Combination Product | Yes |
| 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