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 an updated version of renamic and ics 3000 programmer software, psw 1802. U.
| Device | BELOS, LEXOS, LUMOS, and XELOS |
| Classification Name | Defibrillator, Implantable, Dual-chamber |
| Generic Name | Defibrillator, Implantable, Dual-chamber |
| Applicant | BIOTRONIK, INC. |
| Date Received | 2018-08-22 |
| Decision Date | 2018-10-22 |
| PMA | P000009 |
| Supplement | S077 |
| Product Code | MRM |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |