Home Monitoring System Version 3.48

FDA Premarket Approval P980023 S102

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 NameImplantable Cardioverter Defibrillator (non-crt)
ApplicantBIOTRONIK, INC.
Date Received2020-08-10
Decision Date2020-11-05
PMAP980023
SupplementS102
Product CodeLWS 
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
P980023Original Filing
S102 2020-08-10 Real-time Process
S101 2020-03-26 30-day Notice
S100
S099
S098
S097 2019-12-31 30-day Notice
S096
S095 2019-09-17 30-day Notice
S094 2019-08-15 Real-time Process
S093 2019-07-01 Real-time Process
S092 2019-04-23 30-day Notice
S091 2019-03-18 30-day Notice
S090 2018-12-11 Normal 180 Day Track No User Fee
S089 2018-11-23 Real-time Process
S088 2018-11-16 30-day Notice
S087
S086 2018-07-10 30-day Notice
S085 2018-06-14 135 Review Track For 30-day Notice
S084 2018-01-22 30-day Notice
S083 2017-11-20 30-day Notice
S082 2017-11-20 Real-time Process
S081 2017-04-12 Real-time Process
S080 2017-03-07 30-day Notice
S079 2016-11-21 30-day Notice
S078 2016-09-23 30-day Notice
S077 2016-08-01 30-day Notice
S076 2016-06-06 Normal 180 Day Track
S075 2016-05-24 Normal 180 Day Track
S074 2015-12-23 Normal 180 Day Track
S073 2015-08-03 30-day Notice
S072 2015-04-16 Normal 180 Day Track
S071 2015-06-19 Real-time Process
S070 2015-06-17 Normal 180 Day Track No User Fee
S069 2015-06-15 30-day Notice
S068 2015-05-27 30-day Notice
S067 2015-05-22 30-day Notice
S066 2015-04-29 135 Review Track For 30-day Notice
S065 2015-03-06 135 Review Track For 30-day Notice
S064 2015-02-04 30-day Notice
S063 2015-01-08 30-day Notice
S062 2014-09-24 30-day Notice
S061 2014-09-19 30-day Notice
S060 2014-07-28 Normal 180 Day Track
S059 2014-06-23 30-day Notice
S058 2014-05-30 30-day Notice
S057 2014-01-27 Normal 180 Day Track
S056 2013-06-14 Real-time Process
S055 2013-04-29 30-day Notice
S054 2013-04-24 135 Review Track For 30-day Notice
S053 2013-04-22 30-day Notice
S052 2013-04-03 Real-time Process
S051 2013-01-14 30-day Notice
S050 2012-12-21 Real-time Process
S049 2012-11-14 Normal 180 Day Track
S048 2012-09-07 30-day Notice
S047 2012-08-29 30-day Notice
S046 2011-11-14 Normal 180 Day Track
S045
S044 2011-04-11 Real-time Process
S043 2010-12-29 Real-time Process
S042
S041 2010-05-28 Normal 180 Day Track No User Fee
S040 2010-04-13 30-day Notice
S039 2010-02-12 30-day Notice
S038 2009-08-19 Normal 180 Day Track
S037 2008-11-20 Real-time Process
S036 2008-11-17 Normal 180 Day Track
S035 2008-10-31 Real-time Process
S034 2008-06-04 135 Review Track For 30-day Notice
S033 2008-05-21 Real-time Process
S032 2008-05-14 Real-time Process
S031 2008-05-14 Normal 180 Day Track
S030 2008-01-07 Real-time Process
S029 2007-07-13 Normal 180 Day Track
S028 2007-06-25 30-day Notice
S027 2006-12-18 Real-time Process
S026 2006-10-12 Real-time Process
S025 2006-09-11 Normal 180 Day Track
S024 2006-06-29 Real-time Process
S023 2006-06-02 Real-time Process
S022 2006-04-10 135 Review Track For 30-day Notice
S021 2006-03-10 Real-time Process
S020 2005-09-06 Normal 180 Day Track
S019 2004-12-19 Normal 180 Day Track
S018 2004-06-14 Real-time Process
S017 2004-04-02 Normal 180 Day Track
S016 2003-09-15 Real-time Process
S015 2003-07-16 Normal 180 Day Track No User Fee
S014 2003-03-10 Normal 180 Day Track
S013 2003-02-19 Normal 180 Day Track
S012 2003-01-27 Normal 180 Day Track
S011 2002-11-20 30-day Notice
S010 2002-07-22 Real-time Process
S009 2002-06-04 Normal 180 Day Track
S008 2002-04-08 Real-time Process
S007 2002-01-22 Normal 180 Day Track
S006 2002-02-04 Real-time Process
S005 2001-06-25 Normal 180 Day Track
S004 2001-04-27 Normal 180 Day Track
S003 1999-11-02 Normal 180 Day Track
S002 1999-06-01 Real-time Process
S001 1999-02-22 Real-time Process

NIH GUDID Devices

Device IDPMASupp
04035479139971 P980023 099
04035479150983 P980023 099
04035479139971 P980023 099
04035479140014 P980023 099
04035479150952 P980023 099
04035479150983 P980023 099
04035479139971 P980023 099
04035479140014 P980023 099
04035479150952 P980023 099
04035479150983 P980023 099
04035479139971 P980023 099
04035479140014 P980023 099
04035479150952 P980023 099
04035479150952 P980023 099
04035479140014 P980023 099
04035479140014 P980023 099
04035479150952 P980023 099
04035479150983 P980023 099
04035479139971 P980023 099
04035479140014 P980023 099
04035479150952 P980023 099
04035479150983 P980023 099
04035479139971 P980023 099
04035479140014 P980023 099
04035479150952 P980023 099
04035479150983 P980023 099
04035479139971 P980023 099
04035479150983 P980023 099
04035479139971 P980023 099
04035479150983 P980023 099
04035479139971 P980023 099
04035479140014 P980023 099
04035479150952 P980023 099
04035479150983 P980023 099
04035479139971 P980023 099
04035479140014 P980023 099
04035479150952 P980023 099
04035479150983 P980023 099
04035479139971 P980023 099
04035479140014 P980023 099
04035479150952 P980023 099
04035479150952 P980023 099
04035479140014 P980023 099
04035479140014 P980023 099
04035479150952 P980023 099
04035479150983 P980023 099
04035479139971 P980023 099
04035479140014 P980023 099
04035479150952 P980023 099
04035479150983 P980023 099
04035479139971 P980023 099
04035479140014 P980023 099
04035479150952 P980023 099
04035479150983 P980023 099
04035479139971 P980023 099
04035479150983 P980023 099

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