Transvene CS/SVC Lead

FDA Premarket Approval P980050 S127

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

For test method updates including technical content changes based on test method validation reports

DeviceTransvene CS/SVC Lead
Generic NameImplantable Cardioverter Defibrillator (non-crt)
ApplicantMEDTRONIC Inc.
Date Received2020-06-26
Decision Date2020-07-22
PMAP980050
SupplementS127
Product CodeLWS 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address MEDTRONIC Inc. 8200 Coral Sea Street ms Mvs11 mounds View, MN 55112

Supplemental Filings

Supplement NumberDateSupplement Type
P980050Original Filing
S127 2020-06-26 30-day Notice
S126 2020-03-23 Real-time Process
S125 2019-12-17 30-day Notice
S124 2019-11-18 30-day Notice
S123
S122 2019-06-10 30-day Notice
S121 2019-02-28 30-day Notice
S120 2018-10-18 30-day Notice
S119 2018-06-20 30-day Notice
S118 2018-06-01 30-day Notice
S117 2018-05-15 30-day Notice
S116 2018-04-09 30-day Notice
S115 2018-03-28 30-day Notice
S114 2018-02-22 30-day Notice
S113 2017-11-20 30-day Notice
S112 2017-06-28 30-day Notice
S111 2017-06-23 30-day Notice
S110 2017-06-07 30-day Notice
S109 2017-01-17 30-day Notice
S108 2016-11-14 30-day Notice
S107 2016-10-05 30-day Notice
S106 2016-09-02 30-day Notice
S105 2016-06-24 30-day Notice
S104 2016-06-01 Normal 180 Day Track
S103 2015-12-28 30-day Notice
S102 2015-12-22 30-day Notice
S101 2015-07-02 Real-time Process
S100 2015-04-17 30-day Notice
S099 2015-04-14 Real-time Process
S098 2015-02-09 30-day Notice
S097 2014-12-22 Normal 180 Day Track
S096 2014-08-27 30-day Notice
S095 2014-08-13 30-day Notice
S094 2014-08-08 30-day Notice
S093 2014-07-24 30-day Notice
S092 2014-07-02 Real-time Process
S091 2014-02-27 30-day Notice
S090 2013-12-24 30-day Notice
S089 2013-12-19 30-day Notice
S088 2013-11-27 30-day Notice
S087 2013-10-30 30-day Notice
S086 2013-10-24 30-day Notice
S085 2013-09-30 30-day Notice
S084 2013-05-17 Real-time Process
S083 2013-04-30 30-day Notice
S082 2013-04-18 Real-time Process
S081 2013-04-10 Normal 180 Day Track No User Fee
S080 2013-03-22 30-day Notice
S079 2012-11-21 30-day Notice
S078 2012-09-28 30-day Notice
S077 2012-09-04 30-day Notice
S076 2012-08-07 Normal 180 Day Track
S075 2012-08-03 30-day Notice
S074 2012-06-11 30-day Notice
S073 2012-04-04 Real-time Process
S072 2012-03-26 Real-time Process
S071 2012-02-29 30-day Notice
S070 2012-02-22 Real-time Process
S069 2011-11-25 30-day Notice
S068 2011-11-21 Normal 180 Day Track
S067 2011-09-19 Real-time Process
S066 2011-07-18 30-day Notice
S065 2011-07-08 30-day Notice
S064 2011-06-28 30-day Notice
S063 2011-06-08 30-day Notice
S062 2011-06-08 135 Review Track For 30-day Notice
S061 2011-04-26 30-day Notice
S060 2011-04-12 30-day Notice
S059 2011-03-22 135 Review Track For 30-day Notice
S058 2011-02-28 30-day Notice
S057 2011-01-04 Normal 180 Day Track
S056 2010-11-12 30-day Notice
S055 2010-10-26 30-day Notice
S054
S053 2010-07-15 30-day Notice
S052 2010-07-15 30-day Notice
S051 2010-07-15 30-day Notice
S050 2010-06-28 135 Review Track For 30-day Notice
S049 2010-05-20 Real-time Process
S048 2010-03-29 30-day Notice
S047 2010-03-01 Real-time Process
S046 2010-01-19 30-day Notice
S045 2010-01-15 Real-time Process
S044 2009-12-30 Normal 180 Day Track No User Fee
S043 2009-12-16 Normal 180 Day Track No User Fee
S042 2009-06-17 Real-time Process
S041 2009-03-02 Normal 180 Day Track
S040 2009-02-05 30-day Notice
S039 2008-12-11 30-day Notice
S038 2008-11-03 30-day Notice
S037 2008-10-17 Real-time Process
S036 2008-08-11 30-day Notice
S035 2008-07-28 Normal 180 Day Track
S034 2008-06-17 30-day Notice
S033 2008-04-14 30-day Notice
S032 2008-03-21 30-day Notice
S031 2007-10-11 30-day Notice
S030 2007-09-28 Normal 180 Day Track
S029 2007-09-17 135 Review Track For 30-day Notice
S028 2007-05-31 30-day Notice
S027 2007-03-09 Real-time Process
S026 2007-03-12 135 Review Track For 30-day Notice
S025 2006-10-17 30-day Notice
S024 2006-06-12 Normal 180 Day Track No User Fee
S023 2006-05-10 135 Review Track For 30-day Notice
S022 2006-02-21 Real-time Process
S021 2006-02-14 Real-time Process
S020 2005-12-09 Normal 180 Day Track
S019 2005-12-08 Real-time Process
S018
S017
S016 2004-06-18 Normal 180 Day Track No User Fee
S015 2003-12-12 Real-time Process
S014 2003-08-22 Normal 180 Day Track No User Fee
S013 2002-12-03 Normal 180 Day Track
S012 2002-02-27 Normal 180 Day Track
S011 2001-12-18 Real-time Process
S010 2001-11-05 Special (immediate Track)
S009 2001-09-24 30-day Notice
S008
S007 2001-07-17 30-day Notice
S006 2001-06-27 Normal 180 Day Track
S005 2001-06-14 Normal 180 Day Track
S004 2001-04-13 Real-time Process
S003 2001-02-05 Normal 180 Day Track
S002 2000-11-06 Real-time Process
S001 2000-06-15 Panel Track

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