LUMOS ICDS/XELOS DR-T ICD/LEXOS ICDS

Defibrillator, Implantable, Dual-chamber

FDA Premarket Approval P000009 S026

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.

Pre-market Approval Supplement Details

Approval for the addition of models 500/540 to the lumax family of icd/crt-dsand ics 3000 programmer. These models would contain:¿ a third programmable cardioversion / defibrillation shock pathway to offer moreprogramming options¿ automatic threshold measurement (atm) feature ¿ electronic module (hardware) updates to support the third programmable shock path¿ modifications to the litronik batteries to increase capacity¿ new standard value of the programmable pacing pulse width¿ updated ram firmware to support new features

DeviceLUMOS ICDS/XELOS DR-T ICD/LEXOS ICDS
Classification NameDefibrillator, Implantable, Dual-chamber
Generic NameDefibrillator, Implantable, Dual-chamber
ApplicantBIOTRONIK, INC.
Date Received2008-05-14
Decision Date2008-11-04
PMAP000009
SupplementS026
Product CodeMRM
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address BIOTRONIK, INC. 6024 Jean Road lake Oswego, OR 97035

Supplemental Filings

Supplement NumberDateSupplement Type
P000009Original 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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.