Approval for the addition of the thoracic impedance (ti) measurement feature to the currently approved lumax 500/540 implantable cardioverter defibrillators and cardiac resynchronization defibrillator devices.
Device | LUMAX 500/540 ICDS THORACIC IMPEDANCE |
Classification Name | Defibrillator, Implantable, Dual-chamber |
Generic Name | Defibrillator, Implantable, Dual-chamber |
Applicant | BIOTRONIK, INC. |
Date Received | 2011-08-22 |
Decision Date | 2011-11-17 |
PMA | P050023 |
Supplement | S047 |
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 |
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