CAPSURE FIX NOVUS MRI SURESCAN LEAD MODELS 5076 AND 4076

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

FDA Premarket Approval P930039 S168

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

Approval for 1. 5 and 3t mr conditional labeling for mri surescan lead model 6946m.

DeviceCAPSURE FIX NOVUS MRI SURESCAN LEAD MODELS 5076 AND 4076
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 Received2017-01-25
Decision Date2017-04-25
PMAP930039
SupplementS168
Product CodeNVN
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
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
S248 2023-01-09 30-day Notice
S247 2022-11-16 30-day Notice
S246 2022-10-19 30-day Notice
S245 2022-09-13 30-day Notice
S244 2022-06-17 Normal 180 Day Track No User Fee
S243 2022-05-20 30-day Notice
S242 2022-05-10 30-day Notice
S241 2022-04-14 30-day Notice
S240 2022-03-21 30-day Notice
S239 2022-02-23 30-day Notice
S238
S237 2022-01-28 30-day Notice
S236 2022-01-13 30-day Notice
S235 2021-11-19 30-day Notice
S234
S233
S232 2021-09-24 30-day Notice
S231 2021-09-23 30-day Notice
S230 2021-08-20 30-day Notice
S229 2021-08-09 30-day Notice
S228 2021-06-15 30-day Notice
S227 2021-05-03 30-day Notice
S226 2021-04-28 30-day Notice
S225 2021-04-20 30-day Notice
S224 2021-03-19 30-day Notice
S223 2021-02-05 30-day Notice
S222 2020-12-08 30-day Notice
S221 2020-12-07 30-day Notice
S220
S219 2020-12-01 30-day Notice
S218
S217 2020-10-23 30-day Notice
S216 2020-10-15 30-day Notice
S215 2020-09-17 30-day Notice
S214 2020-07-09 30-day Notice
S213 2020-07-08 30-day Notice
S212
S211 2020-03-23 Real-time Process
S210 2020-02-20 30-day Notice
S209 2020-01-31 30-day Notice
S208 2019-11-18 30-day Notice
S207 2019-11-18 30-day Notice
S206
S205 2019-11-12 30-day Notice
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
00885074311883 P930039 004
00885074311876 P930039 004
00885074311869 P930039 004
00681490124867 P930039 009
00681490124812 P930039 009
00681490730068 P930039 009
00721902309656 P930039 009
00681490124799 P930039 009
00681490730099 P930039 009
00681490729963 P930039 009
00885074248448 P930039 014
00885074200675 P930039 017
00885074200699 P930039 017
00885074200682 P930039 017
00613994329387 P930039 017
00613994329394 P930039 017
00613994329400 P930039 017
00613994776853 P930039 020
00613994776822 P930039 020
00643169448926 P930039 107
00643169448919 P930039 107
00643169448902 P930039 107
00643169448896 P930039 107
00643169448889 P930039 107
00643169448872 P930039 107
00643169550803 P930039 115
00643169550742 P930039 115
00643169550759 P930039 115
00643169550766 P930039 115
00643169550872 P930039 115
00643169550865 P930039 115
00643169550858 P930039 115
00643169550841 P930039 115
00643169550834 P930039 115
00643169550827 P930039 115
00643169550773 P930039 115
00643169550780 P930039 115
00643169550797 P930039 115
00643169550810 P930039 115
00643169633780 P930039 123
00643169633759 P930039 123
00763000014681 P930039 123
00643169633773 P930039 123
00763000014704 P930039 123
00763000014711 P930039 123
00763000014728 P930039 123
00643169453180 P930039 123
00643169633735 P930039 123
00763000014698 P930039 123
00643169633766 P930039 123
00643169633742 P930039 123
00643169708228 P930039 149
00643169708211 P930039 149
00643169708198 P930039 149
00643169708181 P930039 149
00643169708174 P930039 149
00763000014674 P930039 149
00643169708204 P930039 149
00763000014643 P930039 149
00763000014650 P930039 149
00763000014667 P930039 149
00763000014636 P930039 149

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