This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for changing the icd battery pre-discharging process.
Device | LEXOS & LUMOS FAMILIES OF ICDS |
Classification Name | Defibrillator, Implantable, Dual-chamber |
Generic Name | Defibrillator, Implantable, Dual-chamber |
Applicant | BIOTRONIK, INC. |
Date Received | 2008-09-25 |
Decision Date | 2009-03-12 |
PMA | P000009 |
Supplement | S030 |
Product Code | MRM |
Advisory Committee | Cardiovascular |
Supplement Type | 135 Review Track For 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | BIOTRONIK, INC. 6024 Jean Road lake Oswego, OR 97035 |
Supplement Number | Date | Supplement Type |
---|---|---|
P000009 | Original Filing | |
S100 | 2022-11-15 | Real-time Process |
S099 | 2022-11-10 | 30-day Notice |
S098 | 2022-06-17 | 30-day Notice |
S097 | 2022-02-07 | Real-time Process |
S096 | ||
S095 | ||
S094 | 2021-07-21 | 30-day Notice |
S093 | 2021-06-21 | 30-day Notice |
S092 | ||
S091 | 2021-05-05 | 30-day Notice |
S090 | 2021-03-16 | Real-time Process |
S089 | 2020-11-23 | 30-day Notice |
S088 | 2020-11-02 | 30-day Notice |
S087 | 2020-08-10 | Real-time Process |
S086 | ||
S085 | 2020-03-26 | 30-day Notice |
S084 | ||
S083 | ||
S082 | ||
S081 | 2019-08-15 | Real-time Process |
S080 | 2019-07-01 | Real-time Process |
S079 | 2019-03-11 | Real-time Process |
S078 | 2018-09-12 | Normal 180 Day Track |
S077 | 2018-08-22 | Real-time Process |
S076 | 2018-05-17 | Real-time Process |
S075 | 2017-10-18 | Real-time Process |
S074 | 2017-06-06 | Real-time Process |
S073 | ||
S072 | 2017-04-20 | Real-time Process |
S071 | 2017-02-16 | Normal 180 Day Track |
S070 | 2016-12-07 | Normal 180 Day Track |
S069 | 2016-08-08 | Normal 180 Day Track |
S068 | 2016-07-28 | Normal 180 Day Track |
S067 | 2016-06-06 | Normal 180 Day Track |
S066 | 2016-03-24 | Real-time Process |
S065 | 2015-12-23 | Normal 180 Day Track |
S064 | 2015-12-16 | Real-time Process |
S063 | 2015-04-16 | Normal 180 Day Track |
S062 | 2015-03-23 | Normal 180 Day Track |
S061 | 2015-02-13 | Real-time Process |
S060 | 2014-09-25 | Normal 180 Day Track |
S059 | 2014-09-24 | 30-day Notice |
S058 | 2014-06-23 | Normal 180 Day Track |
S057 | 2013-11-25 | Normal 180 Day Track |
S056 | 2013-11-07 | Real-time Process |
S055 | 2013-08-15 | Real-time Process |
S054 | 2013-04-03 | Real-time Process |
S053 | ||
S052 | 2012-12-21 | Real-time Process |
S051 | 2012-12-18 | Normal 180 Day Track |
S050 | 2012-07-02 | Real-time Process |
S049 | 2012-03-01 | Normal 180 Day Track |
S048 | 2012-02-17 | Real-time Process |
S047 | 2011-11-02 | Normal 180 Day Track |
S046 | 2011-08-19 | Normal 180 Day Track |
S045 | 2011-04-11 | Real-time Process |
S044 | ||
S043 | 2010-12-13 | Real-time Process |
S042 | 2010-10-28 | Normal 180 Day Track |
S041 | 2010-08-20 | 30-day Notice |
S040 | 2010-06-08 | Normal 180 Day Track |
S039 | 2010-05-28 | Normal 180 Day Track No User Fee |
S038 | 2009-11-25 | Real-time Process |
S037 | ||
S036 | 2009-09-10 | Real-time Process |
S035 | 2009-07-08 | Normal 180 Day Track |
S034 | 2009-02-13 | Real-time Process |
S033 | 2009-01-26 | Normal 180 Day Track |
S032 | 2008-11-17 | Normal 180 Day Track |
S031 | 2008-10-31 | Real-time Process |
S030 | 2008-09-25 | 135 Review Track For 30-day Notice |
S029 | 2008-07-03 | 135 Review Track For 30-day Notice |
S028 | 2008-05-21 | Real-time Process |
S027 | ||
S026 | 2008-05-14 | Normal 180 Day Track |
S025 | 2008-01-15 | Real-time Process |
S024 | 2007-10-26 | Normal 180 Day Track |
S023 | 2007-08-13 | Normal 180 Day Track |
S022 | 2007-07-13 | Normal 180 Day Track |
S021 | 2006-10-12 | Real-time Process |
S020 | 2006-09-11 | Normal 180 Day Track |
S019 | 2006-06-29 | Real-time Process |
S018 | 2006-04-10 | 135 Review Track For 30-day Notice |
S017 | 2006-03-10 | Real-time Process |
S016 | 2005-06-16 | Real-time Process |
S015 | 2005-03-18 | Real-time Process |
S014 | 2005-01-24 | Real-time Process |
S013 | 2004-08-27 | Real-time Process |
S012 | 2004-04-12 | Real-time Process |
S011 | 2004-03-03 | Real-time Process |
S010 | 2003-09-29 | Real-time Process |
S009 | 2003-07-03 | Normal 180 Day Track |
S008 | 2003-02-10 | Normal 180 Day Track |
S007 | 2002-12-19 | Normal 180 Day Track |
S006 | 2002-11-20 | 30-day Notice |
S005 | 2002-09-25 | Real-time Process |
S004 | 2002-03-22 | Panel Track |
S003 | 2002-01-18 | Real-time Process |
S002 | 2001-08-10 | Real-time Process |
S001 | 2000-12-13 | Normal 180 Day Track |