CapSureFix Novus Lead

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

FDA Premarket Approval P930039 S208

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

DeviceCapSureFix Novus 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, Inc.
Date Received2019-11-18
Decision Date2019-11-27
PMAP930039
SupplementS208
Product CodeNVN
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address Medtronic, Inc. 8200 Coral Sea Street N.e. mounds View, MN 55112

Supplemental Filings

Supplement NumberDateSupplement Type
P930039Original Filing
S208 2019-11-18 30-day Notice
S207
S206
S205
S204 2019-09-11 30-day Notice
S203 2019-07-01 30-day Notice
S202
S201 2019-06-20 30-day Notice
S200 2019-06-18 30-day Notice
S199 2019-06-10 30-day Notice
S198 2019-05-29 30-day Notice
S197 2019-05-02 Normal 180 Day Track No User Fee
S196 2019-02-28 30-day Notice
S195 2018-11-21 30-day Notice
S194
S193 2018-10-23 30-day Notice
S192 2018-10-18 30-day Notice
S191 2018-09-26 30-day Notice
S190 2018-06-20 30-day Notice
S189 2018-06-01 30-day Notice
S188 2018-05-15 30-day Notice
S187 2018-05-11 30-day Notice
S186 2018-04-13 Normal 180 Day Track
S185 2018-04-09 30-day Notice
S184 2018-04-06 30-day Notice
S183 2018-03-28 30-day Notice
S182 2018-03-16 30-day Notice
S181 2018-03-06 30-day Notice
S180 2018-02-22 30-day Notice
S179 2017-12-04 Real-time Process
S178 2017-11-20 30-day Notice
S177 2017-10-20 30-day Notice
S176 2017-10-13 30-day Notice
S175 2017-08-07 30-day Notice
S174 2017-06-28 30-day Notice
S173 2017-06-23 30-day Notice
S172 2017-06-07 30-day Notice
S171 2017-06-02 30-day Notice
S170 2017-05-18 Normal 180 Day Track
S169 2017-04-03 Normal 180 Day Track
S168 2017-01-25 Real-time Process
S167 2017-01-24 30-day Notice
S166 2016-12-06 Normal 180 Day Track
S165 2016-12-06 Normal 180 Day Track
S164 2016-11-28 30-day Notice
S163 2016-11-14 30-day Notice
S162 2016-11-02 Normal 180 Day Track
S161 2016-10-05 30-day Notice
S160 2016-09-23 30-day Notice
S159 2016-09-12 30-day Notice
S158 2016-09-02 30-day Notice
S157 2016-08-29 30-day Notice
S156 2016-08-25 30-day Notice
S155 2016-08-02 30-day Notice
S154 2016-07-26 30-day Notice
S153 2016-06-24 30-day Notice
S152 2016-05-03 Normal 180 Day Track
S151 2016-04-15 Normal 180 Day Track
S150 2016-03-23 30-day Notice
S149 2016-03-11 Normal 180 Day Track
S148 2016-03-01 Normal 180 Day Track
S147 2015-12-28 30-day Notice
S146 2015-12-28 30-day Notice
S145 2015-12-22 30-day Notice
S144 2015-12-04 30-day Notice
S143 2015-10-23 30-day Notice
S142 2015-10-13 Normal 180 Day Track
S141 2015-09-30 30-day Notice
S140 2015-09-24 Normal 180 Day Track
S139 2015-09-17 30-day Notice
S138 2015-03-16 Normal 180 Day Track
S137 2015-09-10 30-day Notice
S136 2015-07-20 30-day Notice
S135 2015-07-01 30-day Notice
S134 2015-06-19 30-day Notice
S133 2015-06-18 30-day Notice
S132 2015-05-18 30-day Notice
S131 2015-05-18 30-day Notice
S130 2015-04-20 Normal 180 Day Track
S129 2015-04-17 30-day Notice
S128 2015-04-16 30-day Notice
S127 2015-03-26 30-day Notice
S126 2015-02-26 30-day Notice
S125 2015-02-09 30-day Notice
S124 2015-01-21 30-day Notice
S123 2014-12-08 Normal 180 Day Track
S122 2014-12-08 30-day Notice
S121 2014-09-29 30-day Notice
S120 2014-09-26 30-day Notice
S119 2014-09-15 30-day Notice
S118 2014-08-27 30-day Notice
S117 2014-08-27 30-day Notice
S116 2014-08-12 30-day Notice
S115 2014-08-08 30-day Notice
S114 2014-07-28 30-day Notice
S113 2014-07-24 30-day Notice
S112 2014-07-11 30-day Notice
S111 2014-06-19 30-day Notice
S110 2014-06-16 30-day Notice
S109 2014-05-22 30-day Notice
S108 2014-05-12 30-day Notice
S107 2014-04-17 Normal 180 Day Track
S106 2014-03-07 30-day Notice
S105 2014-02-27 30-day Notice
S104 2014-01-29 30-day Notice
S103 2014-01-22 30-day Notice
S102 2013-12-24 30-day Notice
S101 2013-12-19 30-day Notice
S100 2013-12-17 30-day Notice
S099
S098 2013-12-12 30-day Notice
S097 2013-11-27 30-day Notice
S096 2013-10-30 30-day Notice
S095 2013-10-24 30-day Notice
S094 2013-09-30 30-day Notice
S093 2013-09-17 30-day Notice
S092 2013-06-07 30-day Notice
S091
S090 2013-05-21 30-day Notice
S089 2013-05-17 Real-time Process
S088 2013-04-30 30-day Notice
S087 2013-04-25 30-day Notice
S086
S085 2013-04-09 Normal 180 Day Track No User Fee
S084 2013-03-22 30-day Notice
S083 2013-03-20 30-day Notice
S082 2013-01-14 30-day Notice
S081 2012-12-17 30-day Notice
S080 2012-12-10 30-day Notice
S079 2012-11-29 30-day Notice
S078 2012-11-21 30-day Notice
S077 2012-11-01 30-day Notice
S076 2012-10-22 30-day Notice
S075 2012-09-28 30-day Notice
S074 2012-09-21 30-day Notice
S073 2012-09-04 30-day Notice
S072 2012-08-31 Normal 180 Day Track No User Fee
S071 2012-08-03 30-day Notice
S070 2012-07-18 30-day Notice
S069 2012-07-13 30-day Notice
S068 2012-06-11 30-day Notice
S067 2012-03-09 30-day Notice
S066 2012-02-29 30-day Notice
S065 2011-11-25 30-day Notice
S064 2011-11-21 Normal 180 Day Track
S063 2011-10-24 135 Review Track For 30-day Notice
S062 2011-08-12 30-day Notice
S061 2011-07-18 30-day Notice
S060 2011-07-08 30-day Notice
S059 2011-06-28 30-day Notice
S058 2011-06-27 30-day Notice
S057 2011-06-08 30-day Notice
S056 2011-06-08 135 Review Track For 30-day Notice
S055 2011-06-01 30-day Notice
S054
S053 2011-05-13 30-day Notice
S052 2011-04-26 30-day Notice
S051 2011-04-22 30-day Notice
S050 2011-03-22 135 Review Track For 30-day Notice
S049 2011-03-18 135 Review Track For 30-day Notice
S048 2011-02-28 30-day Notice
S047 2010-11-12 30-day Notice
S046 2010-10-26 30-day Notice
S045 2010-09-29 30-day Notice
S044
S043 2010-07-28 30-day Notice
S042 2010-07-15 30-day Notice
S041 2010-07-15 30-day Notice
S040 2010-07-15 30-day Notice
S039 2010-06-28 135 Review Track For 30-day Notice
S038
S037 2010-04-19 30-day Notice
S036 2010-03-29 30-day Notice
S035 2010-01-19 30-day Notice
S034 2009-10-09 30-day Notice
S033 2009-10-08 Real-time Process
S032 2009-04-10 30-day Notice
S031 2009-03-17 Real-time Process
S030 2009-02-05 30-day Notice
S029 2008-12-11 30-day Notice
S028
S027 2008-04-23 135 Review Track For 30-day Notice
S026 2008-03-24 30-day Notice
S025 2008-03-10 135 Review Track For 30-day Notice
S024 2008-01-04 30-day Notice
S023 2007-06-27 30-day Notice
S022 2007-05-18 30-day Notice
S021
S020 2004-09-10 Normal 180 Day Track
S019 2004-03-01 135 Review Track For 30-day Notice
S018 2004-02-10 30-day Notice
S017 2003-11-13 Real-time Process
S016 2003-07-02 Real-time Process
S015 2003-03-04 30-day Notice
S014 2002-12-24 Real-time Process
S013 2001-11-14 Real-time Process
S012 2001-11-05 Special (immediate Track)
S011
S010 2001-07-17 30-day Notice
S009 2000-03-13 Normal 180 Day Track
S008 2000-01-11 30-day Notice
S007 2000-01-05 30-day Notice
S006 1998-04-20
S005 1998-03-02 Normal 180 Day Track
S004 1997-11-17 Normal 180 Day Track
S003 1996-11-21 Normal 180 Day Track
S002 1996-06-24 Normal 180 Day Track
S001 1996-05-02 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00885074248592 P930039 002
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00643169550780 P930039 115
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00643169550872 P930039 115
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00763000014711 P930039 123
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00643169633773 P930039 123
00643169633766 P930039 123
00643169633759 P930039 123
00643169633742 P930039 123
00643169633735 P930039 123
00763000014728 P930039 123
00643169708211 P930039 149
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00643169708204 P930039 149
00643169708211 P930039 149
00643169708228 P930039 149
00643169708228 P930039 149

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