Stylet Catheter, Implantable Cardioverter Defibrillator, Implantable Dual-Chamber Defibrillator, Defibrillator Automatic

FDA Premarket Approval P050023 S141

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

Introduce three new sterilization chambers.

DeviceStylet Catheter, Implantable Cardioverter Defibrillator, Implantable Dual-Chamber Defibrillator, Defibrillator Automatic
Generic NameDefibrillator, Implantable, Dual-chamber
ApplicantBIOTRONIK, INC.
Date Received2019-12-31
Decision Date2020-01-29
PMAP050023
SupplementS141
Product CodeMRM 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address BIOTRONIK, INC. 6024 Jean Road lake Oswego, OR 97035

Supplemental Filings

Supplement NumberDateSupplement Type
P050023Original Filing
S141 2019-12-31 30-day Notice
S140 2019-11-27 30-day Notice
S139
S138 2019-10-11 Real-time Process
S137
S136 2019-09-17 30-day Notice
S135 2019-08-19 30-day Notice
S134
S133 2019-07-01 Real-time Process
S132
S131 2019-04-23 30-day Notice
S130 2019-03-11 Real-time Process
S129 2019-01-23 30-day Notice
S128
S127 2018-11-16 30-day Notice
S126
S125 2018-09-12 Normal 180 Day Track
S124 2018-08-22 Real-time Process
S123 2018-07-13 Normal 180 Day Track
S122 2018-07-10 30-day Notice
S121 2018-06-14 135 Review Track For 30-day Notice
S120 2018-05-18 30-day Notice
S119 2018-05-17 Real-time Process
S118 2018-03-05 30-day Notice
S117 2018-02-23 135 Review Track For 30-day Notice
S116 2018-02-09 Normal 180 Day Track
S115 2018-01-22 30-day Notice
S114 2017-11-20 Real-time Process
S113 2017-10-18 Real-time Process
S112 2017-06-06 Real-time Process
S111 2017-05-24 Real-time Process
S110 2017-05-23 Normal 180 Day Track No User Fee
S109 2017-05-05 Real-time Process
S108 2017-04-20 Real-time Process
S107 2017-02-16 Normal 180 Day Track
S106 2017-01-03 30-day Notice
S105 2016-12-07 Normal 180 Day Track
S104 2016-08-08 Normal 180 Day Track
S103 2016-07-28 Normal 180 Day Track
S102 2016-06-09 Real-time Process
S101 2016-06-06 Normal 180 Day Track
S100 2016-06-02 Normal 180 Day Track No User Fee
S099 2016-05-31 30-day Notice
S098 2016-05-12 Real-time Process
S097 2016-03-24 Real-time Process
S096 2016-03-03 30-day Notice
S095 2016-01-21 Normal 180 Day Track No User Fee
S094 2015-12-23 Normal 180 Day Track
S093 2015-12-16 Real-time Process
S092 2015-05-27 30-day Notice
S091 2015-05-19 30-day Notice
S090 2015-05-11 Normal 180 Day Track
S089 2015-04-29 135 Review Track For 30-day Notice
S088 2015-04-16 30-day Notice
S087 2015-04-16 Normal 180 Day Track
S086 2015-03-27 Real-time Process
S085 2015-03-23 Normal 180 Day Track
S084 2015-03-06 135 Review Track For 30-day Notice
S083 2015-02-13 Real-time Process
S082 2014-10-31 30-day Notice
S081 2014-09-25 Normal 180 Day Track
S080 2014-09-24 30-day Notice
S079 2014-08-04 Normal 180 Day Track
S078 2014-07-31 Real-time Process
S077 2014-06-23 Normal 180 Day Track
S076 2014-01-27 Normal 180 Day Track
S075 2014-01-10 Real-time Process
S074 2013-11-25 Normal 180 Day Track
S073 2013-11-12 Real-time Process
S072 2013-11-07 Real-time Process
S071 2013-11-05 30-day Notice
S070 2013-11-05 30-day Notice
S069 2013-08-15 Real-time Process
S068 2013-07-16 30-day Notice
S067 2013-06-14 Real-time Process
S066 2013-06-03 Real-time Process
S065 2013-04-29 30-day Notice
S064 2013-04-22 30-day Notice
S063 2013-04-03 Real-time Process
S062
S061 2013-02-05 Real-time Process
S060 2013-01-14 30-day Notice
S059 2012-12-21 Real-time Process
S058 2012-12-18 Normal 180 Day Track
S057 2012-11-19 Real-time Process
S056 2012-10-12 Normal 180 Day Track No User Fee
S055 2012-09-07 30-day Notice
S054 2012-07-02 Real-time Process
S053 2012-03-01 Normal 180 Day Track
S052 2012-02-17 Real-time Process
S051 2012-02-06 30-day Notice
S050 2012-02-01 Real-time Process
S049 2012-01-30 Real-time Process
S048 2011-11-02 Normal 180 Day Track
S047 2011-08-22 Normal 180 Day Track
S046 2011-08-19 Normal 180 Day Track
S045 2011-04-11 Real-time Process
S044 2011-03-23 30-day Notice
S043 2010-12-23 30-day Notice
S042
S041 2010-12-13 Real-time Process
S040 2010-11-09 30-day Notice
S039 2010-10-28 Normal 180 Day Track
S038 2010-09-30 Real-time Process
S037 2010-08-20 30-day Notice
S036 2010-07-21 30-day Notice
S035 2010-05-18 Normal 180 Day Track No User Fee
S034 2010-06-29 Real-time Process
S033 2010-06-08 Normal 180 Day Track
S032 2010-05-28 Normal 180 Day Track No User Fee
S031 2010-05-11 Real-time Process
S030 2010-04-13 30-day Notice
S029 2010-03-02 Real-time Process
S028 2009-11-25 Real-time Process
S027 2009-09-28 135 Review Track For 30-day Notice
S026 2009-09-10 Real-time Process
S025
S024 2009-07-08 Normal 180 Day Track
S023 2009-03-23 Real-time Process
S022 2009-03-06 30-day Notice
S021 2009-02-13 Real-time Process
S020 2009-01-26 Normal 180 Day Track
S019 2008-11-17 Normal 180 Day Track
S018 2008-10-31 Real-time Process
S017 2008-09-25 135 Review Track For 30-day Notice
S016 2008-09-10 Normal 180 Day Track
S015 2008-07-03 135 Review Track For 30-day Notice
S014 2008-06-04 135 Review Track For 30-day Notice
S013 2008-05-21 Real-time Process
S012 2008-05-14 Real-time Process
S011 2008-05-14 Normal 180 Day Track
S010 2008-01-24 Real-time Process
S009 2008-01-15 Real-time Process
S008 2007-10-26 Normal 180 Day Track
S007 2007-08-13 Normal 180 Day Track
S006 2007-07-13 Normal 180 Day Track
S005 2007-06-25 30-day Notice
S004
S003 2007-01-22 Real-time Process
S002 2006-10-03 Normal 180 Day Track No User Fee
S001 2006-09-11 Normal 180 Day Track

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