Home Monitoring System Version 3.48

FDA Premarket Approval P950037 S214

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 Pacemaker Pulse-generator
ApplicantBIOTRONIK, INC.
Date Received2020-08-10
Decision Date2020-11-05
PMAP950037
SupplementS214
Product CodeDXY 
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
P950037Original Filing
S216 2020-10-28 30-day Notice
S215
S214 2020-08-10 Real-time Process
S213
S212 2020-03-26 30-day Notice
S211
S210
S209 2019-12-31 30-day Notice
S208 2019-11-26 30-day Notice
S207
S206
S205 2019-09-17 30-day Notice
S204 2019-08-15 Real-time Process
S203 2019-06-20 30-day Notice
S202
S201 2019-04-23 30-day Notice
S200
S199 2018-12-10 Normal 180 Day Track No User Fee
S198 2018-11-01 Normal 180 Day Track
S197 2018-09-12 Normal 180 Day Track
S196 2018-09-04 30-day Notice
S195 2018-08-22 Real-time Process
S194 2018-07-13 Normal 180 Day Track
S193 2018-07-10 30-day Notice
S192 2018-06-14 135 Review Track For 30-day Notice
S191 2018-05-18 30-day Notice
S190 2018-05-17 Real-time Process
S189 2018-05-14 30-day Notice
S188
S187 2018-02-23 135 Review Track For 30-day Notice
S186 2018-02-09 Normal 180 Day Track
S185 2018-01-22 30-day Notice
S184 2017-11-20 30-day Notice
S183 2017-11-20 Real-time Process
S182 2017-10-18 Real-time Process
S181 2017-08-23 Real-time Process
S180 2017-08-14 30-day Notice
S179 2017-06-06 Real-time Process
S178 2017-06-02 30-day Notice
S177 2017-05-24 Real-time Process
S176 2017-05-05 Real-time Process
S175 2017-04-20 Real-time Process
S174 2017-04-12 Real-time Process
S173 2017-02-16 Normal 180 Day Track
S172 2017-01-03 30-day Notice
S171 2016-12-07 Normal 180 Day Track
S170 2016-11-21 30-day Notice
S169 2016-11-21 Real-time Process
S168 2016-09-23 30-day Notice
S167 2016-08-08 Normal 180 Day Track
S166 2016-07-28 Normal 180 Day Track
S165 2016-06-09 Real-time Process
S164 2016-06-06 Normal 180 Day Track
S163 2016-05-31 30-day Notice
S162 2016-03-24 Real-time Process
S161 2015-12-23 Normal 180 Day Track
S160 2015-12-16 Real-time Process
S159
S158 2015-08-03 30-day Notice
S157 2015-06-09 30-day Notice
S156 2015-06-01 Normal 180 Day Track
S155 2015-05-27 30-day Notice
S154 2015-05-19 30-day Notice
S153 2015-04-29 135 Review Track For 30-day Notice
S152 2015-04-16 30-day Notice
S151 2015-04-16 Normal 180 Day Track
S150 2015-03-23 Normal 180 Day Track
S149 2015-03-06 135 Review Track For 30-day Notice
S148 2015-02-13 Real-time Process
S147 2015-02-04 30-day Notice
S146 2015-01-08 30-day Notice
S145 2014-11-03 30-day Notice
S144 2014-10-31 30-day Notice
S143 2014-10-14 30-day Notice
S142 2014-09-25 Normal 180 Day Track
S141 2014-09-24 30-day Notice
S140 2014-09-19 30-day Notice
S139 2014-08-04 Normal 180 Day Track
S138 2014-07-28 Normal 180 Day Track
S137 2014-06-23 Normal 180 Day Track
S136 2014-06-23 30-day Notice
S135 2014-06-13 Real-time Process
S134 2014-05-30 30-day Notice
S133 2013-12-09 30-day Notice
S132 2013-11-25 Normal 180 Day Track
S131 2013-11-07 Real-time Process
S130 2013-11-05 30-day Notice
S129 2013-11-05 30-day Notice
S128 2013-08-15 Real-time Process
S127 2013-07-29 Real-time Process
S126 2013-07-16 30-day Notice
S125 2013-06-03 Real-time Process
S124 2013-05-20 Real-time Process
S123 2013-04-29 30-day Notice
S122 2013-04-22 30-day Notice
S121 2013-04-03 Real-time Process
S120
S119 2013-02-05 Real-time Process
S118 2013-01-14 30-day Notice
S117 2012-12-21 Real-time Process
S116 2012-12-18 Normal 180 Day Track
S115
S114 2012-12-03 30-day Notice
S113 2012-11-19 Real-time Process
S112 2012-09-07 30-day Notice
S111 2012-08-10 Real-time Process
S110 2012-07-02 Real-time Process
S109 2012-06-18 Real-time Process
S108 2012-04-05 Real-time Process
S107 2012-04-02 135 Review Track For 30-day Notice
S106
S105 2012-03-01 Normal 180 Day Track
S104 2012-02-17 Real-time Process
S103 2012-02-06 30-day Notice
S102 2012-01-30 Real-time Process
S101 2012-01-27 Real-time Process
S100 2011-11-02 Normal 180 Day Track
S099 2011-10-03 Real-time Process
S098 2011-08-19 Normal 180 Day Track
S097 2011-06-16 135 Review Track For 30-day Notice
S096 2011-04-11 Real-time Process
S095 2011-03-23 30-day Notice
S094 2011-03-10 30-day Notice
S093
S092 2010-12-13 Real-time Process
S091 2010-12-10 Normal 180 Day Track
S090 2010-11-09 30-day Notice
S089 2010-10-28 Normal 180 Day Track
S088 2010-10-06 Normal 180 Day Track
S087
S086 2010-08-20 30-day Notice
S085 2010-08-12 30-day Notice
S084 2010-07-14 Normal 180 Day Track
S083 2010-06-08 Normal 180 Day Track
S082 2010-05-28 Normal 180 Day Track No User Fee
S081 2010-05-11 Real-time Process
S080 2010-04-13 30-day Notice
S079 2010-03-23 Normal 180 Day Track
S078 2010-03-02 Real-time Process
S077 2010-02-12 30-day Notice
S076 2009-11-25 Real-time Process
S075
S074 2009-11-24 Real-time Process
S073 2009-09-10 Real-time Process
S072 2009-07-08 Normal 180 Day Track
S071 2009-03-23 Real-time Process
S070 2009-03-06 30-day Notice
S069 2009-02-13 Real-time Process
S068 2009-01-26 Normal 180 Day Track
S067 2008-11-17 Normal 180 Day Track
S066 2008-10-31 Real-time Process
S065 2008-10-17 Real-time Process
S064 2008-10-17 Real-time Process
S063 2008-09-05 30-day Notice
S062 2008-06-04 135 Review Track For 30-day Notice
S061 2008-05-21 Real-time Process
S060 2008-05-14 Real-time Process
S059 2008-05-14 Normal 180 Day Track
S058 2008-03-18 Real-time Process
S057 2008-02-04 Normal 180 Day Track
S056 2008-01-07 Real-time Process
S055 2007-10-23 Real-time Process
S054 2007-08-13 Normal 180 Day Track
S053 2007-07-13 Normal 180 Day Track
S052 2007-06-25 30-day Notice
S051 2007-04-10 Real-time Process
S050 2007-01-22 Real-time Process
S049 2007-01-11 Real-time Process
S048 2006-12-13 Real-time Process
S047 2006-10-12 Real-time Process
S046 2006-09-11 Normal 180 Day Track
S045 2006-06-29 Real-time Process
S044 2006-04-10 135 Review Track For 30-day Notice
S043 2006-02-24 Real-time Process
S042 2005-11-09 Normal 180 Day Track
S041 2005-09-26 Real-time Process
S040
S039 2004-08-09 Normal 180 Day Track
S038 2004-05-27 Normal 180 Day Track
S037 2004-02-12 Real-time Process
S036 2003-11-03 Normal 180 Day Track
S035 2003-07-28 Normal 180 Day Track
S034 2003-07-14 Normal 180 Day Track
S033 2003-06-24 Normal 180 Day Track
S032 2003-02-28 Normal 180 Day Track
S031 2003-02-06 Real-time Process
S030 2003-01-09 Normal 180 Day Track
S029 2002-11-20 30-day Notice
S028 2002-11-15 Real-time Process
S027
S026
S025
S024 2001-12-31 Normal 180 Day Track
S023 2002-02-11 Normal 180 Day Track
S022 2001-09-28 Real-time Process
S021 2001-07-27 Normal 180 Day Track
S020 2001-06-11 Normal 180 Day Track
S019 2001-02-23 Normal 180 Day Track
S018 2001-01-12 Real-time Process
S017 2000-09-27 Normal 180 Day Track
S016 2000-10-06 Real-time Process
S015 2000-08-07 Real-time Process
S014 2000-05-30 30-day Notice
S013 2000-05-08 Normal 180 Day Track
S012 2000-05-15 Real-time Process
S011 2000-04-13 Real-time Process
S010
S009 1999-05-14 Real-time Process
S008 1999-03-01 Normal 180 Day Track
S007 1999-01-20 Normal 180 Day Track
S006 1998-12-10 Normal 180 Day Track
S005 1998-10-26 Real-time Process
S004 1998-08-31 Real-time Process
S003 1998-06-09 Real-time Process
S002 1998-07-06 Real-time Process
S001 1997-03-31 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
04035479049218 P950037 024
04035479049232 P950037 024
04035479049232 P950037 024
04035479049218 P950037 024
04035479148843 P950037 066
04035479148843 P950037 066
04035479109790 P950037 072
04035479143176 P950037 079
04035479143176 P950037 079
04035479143183 P950037 088
04035479143183 P950037 088
04035479143190 P950037 088
04035479143190 P950037 088
04035479143183 P950037 088
04035479143190 P950037 088
04035479062279 P950037 089
04035479144258 P950037 121
04035479144258 P950037 121
04035479140380 P950037 132
04035479140380 P950037 132
04035479140670 P950037 137
04035479140670 P950037 137
04035479148867 P950037 139
04035479148867 P950037 139
04035479147143 P950037 142
04035479147143 P950037 142
04035479149260 P950037 148
04035479149260 P950037 148
04035479150204 P950037 150
04035479150204 P950037 150
04035479150211 P950037 151
04035479152765 P950037 161
04035479152765 P950037 161
04035479154165 P950037 162
04035479154165 P950037 162
04035479161750 P950037 166
04035479166106 P950037 166
04035479161743 P950037 166
04035479166403 P950037 166
04035479167493 P950037 166
04035479166106 P950037 166
04035479166403 P950037 166
04035479166403 P950037 166
04035479161750 P950037 166
04035479166106 P950037 166
04035479161743 P950037 166
04035479161750 P950037 166
04035479167493 P950037 166
04035479167493 P950037 166
04035479147686 P950037 167
04035479147686 P950037 167
04035479147686 P950037 167
04035479147686 P950037 167
04035479147686 P950037 167
04035479147686 P950037 167
04035479147686 P950037 167
04035479147686 P950037 167
04035479147686 P950037 167
04035479147686 P950037 167
04035479147686 P950037 167
04035479147686 P950037 167
04035479157678 P950037 173
04035479157678 P950037 173
04035479169466 P950037 197
04035479168773 P950037 197
04035479169466 P950037 197
04035479169466 P950037 197
04035479167509 P950037 197
04035479168773 P950037 197
04035479168773 P950037 197
04035479168773 P950037 197
04035479167509 P950037 197
04035479168773 P950037 197
04035479169466 P950037 197
04035479169466 P950037 197
04035479169466 P950037 197
04035479169466 P950037 197
04035479169466 P950037 197
04035479169466 P950037 197
04035479169466 P950037 197
04035479167509 P950037 197
04035479168773 P950037 197
04035479169466 P950037 197
04035479169466 P950037 197
04035479169466 P950037 197
04035479169466 P950037 197
04035479166397 P950037 211
04035479166397 P950037 211
04035479166397 P950037 211
04035479166397 P950037 211
04035479166397 P950037 211
04035479166397 P950037 211
04035479166397 P950037 211
04035479166397 P950037 211
04035479166397 P950037 211
04035479166397 P950037 211
04035479166397 P950037 211
04035479166397 P950037 211
04035479166397 P950037 211
04035479166397 P950037 211
04035479166397 P950037 211
04035479166397 P950037 211

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