Approval for the lumax implantable cardioverter defibrillators (icds), models 300 vr, 340 vr, 300 vr-t, 340 vr-t, 300 dr, 340 dr, 300 dr-t, 340 dr-t, 300 hf, 340 hf, 300 hf-t and 340 hf-t and programmer software version 603. U for use with the lumax family of icds and biotronik, inc. Pacers, single chamber icds and dual chamber icds. The device, as modified, will be marketed under the trade name lumax, and is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias and/or for providing treatment of congestive heart failure.
| Device | LUMAX FAMILY OF ICDS/CRT-DS |
| Classification Name | Defibrillator, Implantable, Dual-chamber |
| Generic Name | Defibrillator, Implantable, Dual-chamber |
| Applicant | BIOTRONIK, INC. |
| Date Received | 2006-09-11 |
| Decision Date | 2006-12-07 |
| PMA | P050023 |
| Supplement | S001 |
| Product Code | MRM |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |
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