Drug Eluting Permanent Left Ventricular (LV) Pacemaker Electrodes

FDA Premarket Approval P070008 S113

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

To update the manufacturing process to be semi-automatic for the silicone sleeve used in sentus otw qp leads

DeviceDrug Eluting Permanent Left Ventricular (LV) Pacemaker Electrodes
Generic NamePulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p)
ApplicantBIOTRONIK, INC.
Date Received2020-02-18
Decision Date2020-03-16
PMAP070008
SupplementS113
Product CodeNKE 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address BIOTRONIK, INC. 6024 Jean Road lake Oswego, OR 97035

Supplemental Filings

Supplement NumberDateSupplement Type
P070008Original Filing
S113 2020-02-18 30-day Notice
S112
S111 2019-12-31 30-day Notice
S110
S109
S108 2019-09-17 30-day Notice
S107 2019-08-30 Normal 180 Day Track No User Fee
S106 2019-08-15 Real-time Process
S105 2019-06-20 30-day Notice
S104
S103 2019-04-23 30-day Notice
S102 2019-03-18 30-day Notice
S101
S100 2019-01-23 30-day Notice
S099
S098 2018-09-12 Normal 180 Day Track
S097 2018-08-22 Real-time Process
S096 2018-07-13 Normal 180 Day Track
S095 2018-07-10 30-day Notice
S094 2018-06-14 135 Review Track For 30-day Notice
S093 2018-05-18 30-day Notice
S092 2018-05-17 Real-time Process
S091 2018-02-23 135 Review Track For 30-day Notice
S090 2018-02-09 Normal 180 Day Track
S089 2018-01-22 30-day Notice
S088 2017-11-20 Real-time Process
S087 2017-10-18 Real-time Process
S086 2017-07-03 30-day Notice
S085 2017-06-06 Real-time Process
S084 2017-05-24 Real-time Process
S083 2017-05-05 Real-time Process
S082 2017-04-20 Real-time Process
S081 2017-02-16 Normal 180 Day Track
S080 2017-01-03 30-day Notice
S079 2016-12-07 Normal 180 Day Track
S078
S077 2016-11-21 Real-time Process
S076 2016-08-08 Normal 180 Day Track
S075 2016-07-28 Normal 180 Day Track
S074 2016-06-06 Normal 180 Day Track
S073 2016-05-31 30-day Notice
S072 2016-03-24 Real-time Process
S071 2016-03-03 30-day Notice
S070 2015-12-23 Normal 180 Day Track
S069 2015-12-16 Real-time Process
S068 2015-08-03 30-day Notice
S067 2015-06-09 30-day Notice
S066 2015-05-27 30-day Notice
S065 2015-05-19 30-day Notice
S064 2015-04-29 135 Review Track For 30-day Notice
S063 2015-04-16 Normal 180 Day Track
S062 2015-03-23 Normal 180 Day Track
S061 2015-03-06 135 Review Track For 30-day Notice
S060 2015-02-13 Real-time Process
S059 2015-02-04 30-day Notice
S058 2014-10-31 30-day Notice
S057 2014-09-25 Normal 180 Day Track
S056 2014-09-24 30-day Notice
S055 2014-09-19 30-day Notice
S054 2014-07-28 Normal 180 Day Track
S053 2014-06-23 Normal 180 Day Track
S052 2014-06-23 30-day Notice
S051 2014-05-30 30-day Notice
S050 2013-11-25 Normal 180 Day Track
S049 2013-11-07 Real-time Process
S048 2013-11-05 30-day Notice
S047 2013-08-15 Real-time Process
S046 2013-07-29 Real-time Process
S045 2013-07-16 30-day Notice
S044 2013-06-03 Real-time Process
S043 2013-04-29 30-day Notice
S042 2013-04-22 30-day Notice
S041 2013-04-03 Real-time Process
S040
S039 2013-02-05 Real-time Process
S038 2013-01-14 30-day Notice
S037 2012-12-21 Real-time Process
S036 2012-12-18 Normal 180 Day Track
S035 2012-11-19 Real-time Process
S034 2012-09-07 30-day Notice
S033 2012-07-02 Real-time Process
S032 2012-04-02 135 Review Track For 30-day Notice
S031 2012-03-01 Normal 180 Day Track
S030 2012-02-17 Real-time Process
S029 2012-02-06 30-day Notice
S028 2011-11-02 Normal 180 Day Track
S027 2011-10-03 Real-time Process
S026 2011-08-19 Normal 180 Day Track
S025 2011-06-23 30-day Notice
S024 2011-06-16 135 Review Track For 30-day Notice
S023 2011-04-11 Real-time Process
S022
S021 2010-12-13 Real-time Process
S020 2010-11-09 30-day Notice
S019 2010-10-28 Normal 180 Day Track
S018 2010-08-20 30-day Notice
S017 2010-06-08 Normal 180 Day Track
S016 2010-05-28 Normal 180 Day Track No User Fee
S015 2010-02-24 Normal 180 Day Track
S014 2009-11-25 Real-time Process
S013 2009-09-30 Real-time Process
S012 2009-09-10 Real-time Process
S011 2009-07-08 Normal 180 Day Track
S010 2009-02-13 Real-time Process
S009 2009-01-26 Normal 180 Day Track
S008 2008-11-17 Normal 180 Day Track
S007 2008-10-31 Real-time Process
S006 2008-09-05 30-day Notice
S005 2008-06-11 Normal 180 Day Track No User Fee
S004 2008-06-04 135 Review Track For 30-day Notice
S003 2008-06-02 Real-time Process
S002 2008-05-15 Real-time Process
S001 2008-05-15 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
04035479148966 P070008 079
04035479145613 P070008 079
04035479138455 P070008 079
04035479138448 P070008 079
04035479138431 P070008 079
04035479138424 P070008 079
04035479138417 P070008 079
04035479138400 P070008 079

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