Home Monitoring System Version 3.48

FDA Premarket Approval P000009 S087

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 to introduce a physician notification system component under the current home monitoring system, version 3. 49.

DeviceHome Monitoring System Version 3.48
Generic NameDefibrillator, Implantable, Dual-chamber
ApplicantBIOTRONIK, INC.
Date Received2020-08-10
Decision Date2020-11-05
PMAP000009
SupplementS087
Product CodeMRM 
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
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
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

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.