CapSure Sense Lead

Drug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes

FDA Premarket Approval P830061 S178

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

Minor changes to the final device acceptance-functional test for leads

DeviceCapSure Sense Lead
Classification NameDrug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes
Generic NameDrug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
Date Received2019-11-18
Decision Date2019-11-27
PMAP830061
SupplementS178
Product CodeNVN
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 Coral Sea Street N.e. mounds View, MN 55112

Supplemental Filings

Supplement NumberDateSupplement Type
P830061Original Filing
S178 2019-11-18 30-day Notice
S177 2019-11-18 30-day Notice
S176
S175 2019-09-16 30-day Notice
S174 2019-07-01 30-day Notice
S173
S172 2019-06-20 30-day Notice
S171 2019-06-18 30-day Notice
S170 2019-06-10 30-day Notice
S169 2019-05-29 30-day Notice
S168 2019-05-02 Normal 180 Day Track No User Fee
S167 2019-02-28 30-day Notice
S166 2018-11-21 30-day Notice
S165
S164 2018-10-23 30-day Notice
S163 2018-10-18 30-day Notice
S162 2018-09-26 30-day Notice
S161 2018-06-20 30-day Notice
S160 2018-06-01 30-day Notice
S159 2018-05-15 30-day Notice
S158 2018-05-11 30-day Notice
S157 2018-04-13 Normal 180 Day Track
S156 2018-04-09 30-day Notice
S155 2018-03-28 30-day Notice
S154 2018-02-22 30-day Notice
S153 2017-12-04 Real-time Process
S152 2017-11-20 30-day Notice
S151 2017-10-20 30-day Notice
S150 2017-10-13 30-day Notice
S149 2017-08-07 30-day Notice
S148 2017-06-28 30-day Notice
S147 2017-06-23 30-day Notice
S146 2017-06-07 30-day Notice
S145 2017-05-18 Normal 180 Day Track
S144 2017-04-03 Normal 180 Day Track
S143 2017-01-25 Real-time Process
S142 2017-01-17 30-day Notice
S141 2016-12-06 Normal 180 Day Track
S140 2016-12-06 Normal 180 Day Track
S139 2016-11-28 30-day Notice
S138 2016-11-14 30-day Notice
S137 2016-11-02 Normal 180 Day Track
S136 2016-10-05 30-day Notice
S135 2016-09-12 30-day Notice
S134 2016-09-02 30-day Notice
S133 2016-08-29 30-day Notice
S132 2016-08-25 30-day Notice
S131 2016-06-24 30-day Notice
S130 2016-05-03 Normal 180 Day Track
S129 2016-04-15 Normal 180 Day Track
S128 2016-03-17 30-day Notice
S127 2016-03-11 Normal 180 Day Track
S126
S125 2015-12-22 30-day Notice
S124 2015-12-04 30-day Notice
S123 2015-12-01 30-day Notice
S122 2015-09-10 30-day Notice
S121 2015-04-17 30-day Notice
S120 2015-04-16 30-day Notice
S119 2015-03-25 30-day Notice
S118 2015-02-09 30-day Notice
S117 2014-09-29 30-day Notice
S116 2014-09-26 30-day Notice
S115 2014-08-27 30-day Notice
S114 2014-08-12 30-day Notice
S113 2014-08-08 30-day Notice
S112 2014-07-24 30-day Notice
S111 2014-07-14 30-day Notice
S110 2014-07-11 30-day Notice
S109 2014-06-19 30-day Notice
S108 2014-02-27 30-day Notice
S107 2014-01-29 30-day Notice
S106 2014-01-22 30-day Notice
S105 2013-12-24 30-day Notice
S104 2013-12-19 30-day Notice
S103
S102 2013-12-12 30-day Notice
S101 2013-11-27 30-day Notice
S100 2013-10-30 30-day Notice
S099 2013-10-24 30-day Notice
S098 2013-09-30 30-day Notice
S097 2013-09-17 30-day Notice
S096 2013-06-07 30-day Notice
S095
S094 2013-05-21 30-day Notice
S093 2013-05-17 Real-time Process
S092 2013-04-30 30-day Notice
S091 2013-04-25 30-day Notice
S090
S089 2013-04-10 Normal 180 Day Track No User Fee
S088 2013-03-22 30-day Notice
S087 2013-03-20 30-day Notice
S086 2013-03-13 Normal 180 Day Track
S085 2013-01-14 30-day Notice
S084 2012-12-10 30-day Notice
S083 2012-11-29 30-day Notice
S082 2012-11-21 30-day Notice
S081
S080 2012-10-17 30-day Notice
S079 2012-09-28 30-day Notice
S078 2012-09-04 30-day Notice
S077 2012-08-03 30-day Notice
S076 2012-06-11 30-day Notice
S075 2012-02-29 30-day Notice
S074 2011-11-25 30-day Notice
S073 2011-11-21 Normal 180 Day Track
S072 2011-10-24 135 Review Track For 30-day Notice
S071 2011-07-18 30-day Notice
S070 2011-07-08 30-day Notice
S069 2011-06-28 30-day Notice
S068 2011-06-27 30-day Notice
S067 2011-06-08 30-day Notice
S066 2011-06-08 135 Review Track For 30-day Notice
S065 2011-05-13 30-day Notice
S064 2011-05-05 Normal 180 Day Track No User Fee
S063 2011-04-26 30-day Notice
S062 2011-03-22 135 Review Track For 30-day Notice
S061 2011-03-18 135 Review Track For 30-day Notice
S060 2011-02-28 30-day Notice
S059 2010-11-12 30-day Notice
S058 2010-10-26 30-day Notice
S057 2010-09-29 30-day Notice
S056
S055 2010-07-15 30-day Notice
S054 2010-07-15 30-day Notice
S053 2010-07-15 30-day Notice
S052 2010-06-28 135 Review Track For 30-day Notice
S051 2010-04-19 30-day Notice
S050 2010-03-29 30-day Notice
S049 2010-01-19 30-day Notice
S048 2010-01-15 Real-time Process
S047 2009-10-08 Real-time Process
S046 2009-03-17 Real-time Process
S045 2009-02-05 30-day Notice
S044 2008-12-11 30-day Notice
S043
S042 2008-04-23 135 Review Track For 30-day Notice
S041 2008-03-24 30-day Notice
S040 2008-03-10 135 Review Track For 30-day Notice
S039 2007-05-18 30-day Notice
S038
S037 2004-03-01 135 Review Track For 30-day Notice
S036 2003-03-04 30-day Notice
S035 2002-12-24 Real-time Process
S034 2002-03-01 Normal 180 Day Track
S033 2001-11-05 Special (immediate Track)
S032 2001-07-17 30-day Notice
S031 2000-01-11 30-day Notice
S030 1999-05-24 Real-time Process
S029 1998-09-01 Normal 180 Day Track
S028 1998-04-20 Normal 180 Day Track
S027 1998-03-02 Normal 180 Day Track
S026 1996-05-02 Normal 180 Day Track
S025 1995-01-30 Normal 180 Day Track
S024 1994-09-08 Normal 180 Day Track
S023 1994-02-14 Normal 180 Day Track
S022 1993-09-29 Normal 180 Day Track
S021 1992-12-24 Normal 180 Day Track
S020
S019 1992-06-15 Normal 180 Day Track
S018
S017 1992-01-27 Special (immediate Track)
S016
S015 1990-01-07 Normal 180 Day Track
S014 1990-07-24 Normal 180 Day Track
S013 1990-05-15 Normal 180 Day Track
S012 1990-05-10 Normal 180 Day Track
S011 1989-11-01 Normal 180 Day Track
S010 1989-08-09 Normal 180 Day Track
S009 1989-03-02 Normal 180 Day Track
S008 1989-01-23 Normal 180 Day Track
S007 1988-10-21 Normal 180 Day Track
S006 1988-07-18 Normal 180 Day Track
S005 1988-01-20 Normal 180 Day Track
S004 1987-03-05 Normal 180 Day Track
S003 1987-02-02 Normal 180 Day Track
S002 1986-09-25 Normal 180 Day Track
S001 1986-09-11 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00681490114974 P830061 027
00681490110655 P830061 027
00681490110716 P830061 027
00681490110778 P830061 027
00681490114943 P830061 027
00681490110655 P830061 027
00681490110716 P830061 027
00681490110778 P830061 027
00681490114943 P830061 027
00681490114974 P830061 027
00885074200996 P830061 027
00885074200989 P830061 027
00613994505439 P830061 034
00763000058975 P830061 034
00763000058920 P830061 034
00763000058968 P830061 034
00763000058975 P830061 034
00885074200637 P830061 034
00613994505439 P830061 034
00613994505477 P830061 034
00613994505484 P830061 034
00763000058968 P830061 034
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00885074200620 P830061 034
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00613994505477 P830061 034
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00885074200941 P830061 034
00885074200958 P830061 034
00613994505484 P830061 034
00885074200613 P830061 034
00681490026901 P830061 073
00681490026901 P830061 073
00763000059446 P830061 073
00763000059446 P830061 073
00613994618139 P830061 073
00613994618139 P830061 073
00643169410824 P830061 086
00643169411074 P830061 086
00643169410824 P830061 086
00643169410831 P830061 086
00643169411074 P830061 086
00643169410978 P830061 086
00643169410985 P830061 086
00643169411012 P830061 086
00643169411029 P830061 086
00643169411067 P830061 086
00643169411081 P830061 086
00643169411098 P830061 086
00643169411104 P830061 086
00643169411104 P830061 086
00643169411029 P830061 086
00643169411012 P830061 086
00643169410978 P830061 086
00643169411067 P830061 086
00643169411081 P830061 086
00643169411098 P830061 086
00643169410831 P830061 086
00643169410985 P830061 086
00643169638716 P830061 113
00643169590472 P830061 113
00643169638648 P830061 113
00643169638723 P830061 113
00643169590540 P830061 113
00643169638631 P830061 113
00643169590489 P830061 113
00643169590496 P830061 113
00643169590519 P830061 113
00643169590533 P830061 113
00643169590526 P830061 113
00643169590533 P830061 113
00643169590502 P830061 113
00643169638631 P830061 113
00643169638648 P830061 113
00643169590526 P830061 113
00643169590519 P830061 113
00643169590502 P830061 113
00643169590496 P830061 113
00643169590489 P830061 113
00643169590472 P830061 113
00643169590465 P830061 113
00643169638716 P830061 113
00643169638723 P830061 113
00643169590465 P830061 113
00643169590540 P830061 113
00643169448858 P830061 127
00643169410961 P830061 127
00643169448940 P830061 127
00643169410954 P830061 127
00643169410947 P830061 127
00643169410916 P830061 127
00643169448865 P830061 127
00643169448940 P830061 127
00643169448957 P830061 127
00643169410916 P830061 127
00643169410954 P830061 127
00643169410961 P830061 127
00643169448957 P830061 127
00643169448858 P830061 127
00643169448865 P830061 127
00643169410947 P830061 127

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