CapSureFix MRI Lead

Implantable Pulse Generator, Pacemaker (non-crt)

FDA Premarket Approval P090013 S304

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 MRI Lead
Classification NameImplantable Pulse Generator, Pacemaker (non-crt)
Generic NameImplantable Pulse Generator, Pacemaker (non-crt)
ApplicantMedtronic, Inc
Date Received2019-11-18
Decision Date2019-11-27
PMAP090013
SupplementS304
Product CodeLWP
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 Ne mounds View, MN 55112

Supplemental Filings

Supplement NumberDateSupplement Type
P090013Original Filing
S304 2019-11-18 30-day Notice
S303
S302
S301
S300 2019-06-20 30-day Notice
S299 2019-06-10 30-day Notice
S298 2019-05-02 Normal 180 Day Track No User Fee
S297
S296 2019-02-28 30-day Notice
S295 2018-11-21 30-day Notice
S294 2018-11-05 30-day Notice
S293
S292 2018-10-23 30-day Notice
S291 2018-10-18 30-day Notice
S290 2018-09-26 30-day Notice
S289 2018-08-22 Real-time Process
S288 2018-06-28 Normal 180 Day Track No User Fee
S287 2018-06-20 30-day Notice
S286 2018-05-15 30-day Notice
S285 2018-05-14 30-day Notice
S284 2018-05-11 30-day Notice
S283 2018-04-23 30-day Notice
S282 2018-04-17 Real-time Process
S281 2018-04-13 Normal 180 Day Track
S280 2018-04-12 30-day Notice
S279 2018-04-12 30-day Notice
S278 2018-04-09 30-day Notice
S277 2018-04-09 30-day Notice
S276 2018-04-06 30-day Notice
S275 2018-03-30 30-day Notice
S274 2018-03-28 30-day Notice
S273 2018-03-16 30-day Notice
S272 2018-03-12 30-day Notice
S271 2018-03-06 30-day Notice
S270 2018-02-01 Real-time Process
S269 2017-12-04 Real-time Process
S268 2017-11-29 30-day Notice
S267 2017-11-20 30-day Notice
S266 2017-11-13 30-day Notice
S265 2017-11-07 30-day Notice
S264 2017-10-16 30-day Notice
S263 2017-09-05 Real-time Process
S262 2017-08-07 30-day Notice
S261 2017-06-23 30-day Notice
S260 2017-06-23 30-day Notice
S259 2017-06-07 30-day Notice
S258 2017-06-02 30-day Notice
S257 2017-05-18 30-day Notice
S256 2017-05-18 Normal 180 Day Track
S255 2017-04-04 30-day Notice
S254 2017-04-03 Normal 180 Day Track
S253 2017-03-31 30-day Notice
S252 2017-03-29 30-day Notice
S251 2017-03-08 30-day Notice
S250 2017-02-09 30-day Notice
S249 2017-02-03 30-day Notice
S248 2017-01-25 Real-time Process
S247 2017-01-24 30-day Notice
S246 2017-01-13 30-day Notice
S245 2016-12-06 Normal 180 Day Track
S244 2016-12-06 Normal 180 Day Track
S243 2016-11-23 Real-time Process
S242 2016-11-16 Normal 180 Day Track
S241 2016-11-14 30-day Notice
S240 2016-11-02 Normal 180 Day Track
S239 2016-10-17 30-day Notice
S238 2016-10-05 30-day Notice
S237 2016-09-26 30-day Notice
S236 2016-09-23 30-day Notice
S235 2016-09-08 Real-time Process
S234 2016-09-02 30-day Notice
S233 2016-08-02 30-day Notice
S232 2016-07-22 30-day Notice
S231 2016-07-13 Real-time Process
S230 2016-06-24 Real-time Process
S229 2016-06-24 30-day Notice
S228 2016-06-22 30-day Notice
S227 2016-06-13 30-day Notice
S226 2016-05-03 Normal 180 Day Track
S225 2016-04-15 Normal 180 Day Track
S224 2016-03-31 30-day Notice
S223 2016-03-18 Real-time Process
S222 2016-03-17 30-day Notice
S221 2016-03-11 Normal 180 Day Track
S220 2016-03-01 Normal 180 Day Track
S219 2016-02-29 30-day Notice
S218 2016-02-25 30-day Notice
S217 2016-02-05 30-day Notice
S216 2016-02-02 30-day Notice
S215 2016-01-12 Real-time Process
S214 2015-12-28 30-day Notice
S213 2015-12-28 30-day Notice
S212 2015-12-22 30-day Notice
S211 2015-12-18 Real-time Process
S210 2015-12-04 30-day Notice
S209 2015-12-01 Normal 180 Day Track
S208 2015-10-23 30-day Notice
S207 2015-10-22 Real-time Process
S206 2015-10-16 Real-time Process
S205 2015-10-13 Normal 180 Day Track
S204 2015-09-30 30-day Notice
S203 2015-09-30 30-day Notice
S202 2015-09-24 Normal 180 Day Track
S201 2015-09-17 30-day Notice
S200 2015-03-16 Normal 180 Day Track
S199 2015-09-10 30-day Notice
S198 2015-08-28 Real-time Process
S197 2015-08-12 30-day Notice
S196 2015-08-11 30-day Notice
S195 2015-07-20 30-day Notice
S194 2015-07-09 30-day Notice
S193 2015-07-02 Real-time Process
S192 2015-07-01 30-day Notice
S191 2015-07-01 30-day Notice
S190 2015-06-24 30-day Notice
S189 2015-06-19 30-day Notice
S188 2015-06-18 30-day Notice
S187 2015-05-22 30-day Notice
S186 2015-04-17 30-day Notice
S185 2015-04-16 30-day Notice
S184 2015-04-14 Real-time Process
S183 2015-04-01 30-day Notice
S182 2015-03-26 30-day Notice
S181 2015-03-23 30-day Notice
S180 2015-03-23 30-day Notice
S179 2015-03-06 Real-time Process
S178 2015-02-26 30-day Notice
S177 2015-02-09 30-day Notice
S176 2015-02-06 30-day Notice
S175 2015-02-05 30-day Notice
S174 2015-02-04 30-day Notice
S173 2015-02-02 30-day Notice
S172 2015-02-02 30-day Notice
S171 2015-01-29 30-day Notice
S170 2015-01-23 30-day Notice
S169 2015-01-22 30-day Notice
S168 2015-01-21 30-day Notice
S167 2015-01-20 30-day Notice
S166 2015-01-12 30-day Notice
S165 2014-12-22 Normal 180 Day Track
S164 2014-12-08 Normal 180 Day Track
S163 2014-12-05 30-day Notice
S162 2014-11-19 30-day Notice
S161 2014-10-02 30-day Notice
S160 2014-09-29 30-day Notice
S159 2014-09-26 30-day Notice
S158 2014-09-19 30-day Notice
S157 2014-09-15 30-day Notice
S156 2014-08-27 30-day Notice
S155 2014-08-27 30-day Notice
S154 2014-08-27 Real-time Process
S153 2014-08-12 30-day Notice
S152 2014-08-08 30-day Notice
S151 2014-08-01 30-day Notice
S150 2014-07-24 30-day Notice
S149 2014-07-18 Normal 180 Day Track
S148 2014-07-11 30-day Notice
S147 2014-07-02 Real-time Process
S146 2014-06-19 30-day Notice
S145 2014-06-16 30-day Notice
S144 2014-06-13 30-day Notice
S143 2014-05-23 30-day Notice
S142 2014-05-12 30-day Notice
S141 2014-05-01 30-day Notice
S140 2014-04-25 30-day Notice
S139 2014-03-28 Real-time Process
S138 2014-03-28 Real-time Process
S137 2014-03-20 30-day Notice
S136 2014-03-18 Real-time Process
S135 2014-03-07 30-day Notice
S134 2014-03-07 30-day Notice
S133 2014-02-27 30-day Notice
S132 2014-02-25 Real-time Process
S131 2014-01-30 30-day Notice
S130 2014-01-29 30-day Notice
S129 2014-01-29 30-day Notice
S128 2014-01-27 30-day Notice
S127 2014-01-22 30-day Notice
S126 2013-12-24 30-day Notice
S125 2013-12-23 30-day Notice
S124 2013-12-19 Real-time Process
S123 2013-12-19 30-day Notice
S122
S121 2013-12-12 30-day Notice
S120 2013-10-30 30-day Notice
S119 2013-10-24 30-day Notice
S118 2013-10-24 30-day Notice
S117 2013-10-17 30-day Notice
S116 2013-10-17 30-day Notice
S115 2013-09-24 30-day Notice
S114 2013-09-17 30-day Notice
S113 2013-09-11 30-day Notice
S112 2013-08-23 Normal 180 Day Track
S111 2013-08-21 30-day Notice
S110 2013-08-12 Real-time Process
S109 2013-07-26 30-day Notice
S108 2013-07-17 30-day Notice
S107 2013-07-08 Normal 180 Day Track
S106 2013-07-02 30-day Notice
S105 2013-06-11 Normal 180 Day Track
S104 2013-06-07 30-day Notice
S103 2013-06-07 30-day Notice
S102 2013-05-29 30-day Notice
S101
S100 2013-05-17 30-day Notice
S099 2013-05-17 Real-time Process
S098 2013-05-13 Real-time Process
S097 2013-04-30 30-day Notice
S096 2013-04-25 30-day Notice
S095 2013-04-23 30-day Notice
S094
S093 2013-04-18 Real-time Process
S092 2013-04-17 30-day Notice
S091 2013-04-10 Normal 180 Day Track No User Fee
S090 2013-03-27 30-day Notice
S089 2013-03-22 30-day Notice
S088 2013-03-11 30-day Notice
S087 2013-03-05 30-day Notice
S086 2013-03-04 30-day Notice
S085 2013-02-26 Normal 180 Day Track
S084 2013-02-26 30-day Notice
S083 2013-01-22 30-day Notice
S082 2013-01-14 30-day Notice
S081 2012-11-21 30-day Notice
S080 2012-11-05 30-day Notice
S079 2012-11-01 30-day Notice
S078 2012-10-22 30-day Notice
S077 2012-10-19 30-day Notice
S076 2012-10-05 30-day Notice
S075 2012-09-28 30-day Notice
S074 2012-09-21 30-day Notice
S073 2012-08-31 Normal 180 Day Track No User Fee
S072 2012-08-24 Real-time Process
S071 2012-08-13 30-day Notice
S070 2012-08-08 30-day Notice
S069 2012-08-03 30-day Notice
S068 2012-07-25 30-day Notice
S067 2012-07-23 30-day Notice
S066 2012-07-18 30-day Notice
S065 2012-06-29 30-day Notice
S064 2012-06-11 30-day Notice
S063 2012-08-21 Normal 180 Day Track
S062
S061 2012-04-04 Real-time Process
S060 2012-03-27 30-day Notice
S059 2012-03-12 Real-time Process
S058 2012-03-09 30-day Notice
S057 2012-03-07 30-day Notice
S056 2012-03-05 30-day Notice
S055 2012-02-29 30-day Notice
S054 2012-02-27 Real-time Process
S053 2012-02-13 30-day Notice
S052
S051 2012-02-07 30-day Notice
S050 2012-02-03 30-day Notice
S049 2011-12-20 30-day Notice
S048 2011-11-25 30-day Notice
S047 2011-11-21 Normal 180 Day Track
S046
S045 2011-11-14 30-day Notice
S044 2011-11-10 Real-time Process
S043 2011-10-25 30-day Notice
S042 2011-10-24 135 Review Track For 30-day Notice
S041 2011-10-06 30-day Notice
S040 2011-09-19 Real-time Process
S039 2011-09-16 30-day Notice
S038 2011-08-12 30-day Notice
S037 2011-08-05 30-day Notice
S036
S035 2011-07-20 30-day Notice
S034 2011-07-18 30-day Notice
S033 2011-07-18 30-day Notice
S032 2011-07-08 30-day Notice
S031 2011-07-06 30-day Notice
S030 2011-06-28 30-day Notice
S029 2011-06-08 30-day Notice
S028 2011-06-08 135 Review Track For 30-day Notice
S027 2011-06-07 30-day Notice
S026 2011-06-01 30-day Notice
S025
S024 2011-05-10 30-day Notice
S023 2011-05-09 30-day Notice
S022 2011-05-04 30-day Notice
S021 2011-04-29 30-day Notice
S020 2011-04-26 30-day Notice
S019 2011-04-25 Real-time Process
S018 2011-04-22 30-day Notice
S017 2011-04-21 30-day Notice
S016 2011-04-19 30-day Notice
S015 2011-04-04 30-day Notice
S014
S013 2011-03-29 Real-time Process
S012 2011-03-29 Real-time Process
S011 2011-03-22 135 Review Track For 30-day Notice
S010 2011-03-18 135 Review Track For 30-day Notice
S009
S008 2011-03-02 30-day Notice
S007 2011-03-02 30-day Notice
S006 2011-03-01 135 Review Track For 30-day Notice
S005 2011-03-01 30-day Notice
S004 2011-02-28 30-day Notice
S003 2011-02-24 30-day Notice
S002 2011-02-18 30-day Notice
S001 2011-02-18 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00613994657374 P090013 000
00613994657350 P090013 000
00613994657367 P090013 000
00613994657374 P090013 000
00613994614742 P090013 000
00613994657367 P090013 000
00613994657350 P090013 000
00613994614742 P090013 000
00643169493407 P090013 137
00643169493407 P090013 137
00643169550995 P090013 152
00643169550988 P090013 152
00643169550995 P090013 152
00643169551008 P090013 152
00643169550988 P090013 152
00643169551008 P090013 152

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