CareLink SmartSync Manager and MyCareLink Patient Monitor

Pulse Generator, Permanent, Implantable

FDA Premarket Approval P890003 S420

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

To update electrical current inspection test limits used for manufacturing rf head assemblies

DeviceCareLink SmartSync Manager and MyCareLink Patient Monitor
Classification NamePulse Generator, Permanent, Implantable
Generic NamePulse Generator, Permanent, Implantable
ApplicantMedtronic, Inc.
Date Received2019-10-21
Decision Date2019-11-12
PMAP890003
SupplementS420
Product CodeNVZ
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 N.e. mounds View, MN 55112

Supplemental Filings

Supplement NumberDateSupplement Type
P890003Original Filing
S420 2019-10-21 30-day Notice
S419 2019-09-16 30-day Notice
S418 2019-07-11 Real-time Process
S417 2019-07-01 30-day Notice
S416
S415 2019-06-21 30-day Notice
S414 2019-06-20 30-day Notice
S413 2019-06-10 30-day Notice
S412
S411
S410 2019-04-23 30-day Notice
S409 2019-03-28 30-day Notice
S408 2019-03-25 Real-time Process
S407
S406 2019-03-18 Real-time Process
S405 2019-02-28 30-day Notice
S404
S403 2019-01-30 Normal 180 Day Track No User Fee
S402 2018-11-21 30-day Notice
S401 2018-11-16 Real-time Process
S400 2018-10-23 30-day Notice
S399 2018-10-18 30-day Notice
S398 2018-10-03 Real-time Process
S397 2018-09-26 30-day Notice
S396 2018-08-22 Real-time Process
S395 2018-08-22 Real-time Process
S394 2018-07-06 Real-time Process
S393 2018-06-20 30-day Notice
S392 2018-06-01 30-day Notice
S391 2018-05-15 30-day Notice
S390 2018-04-17 Real-time Process
S389 2018-04-09 30-day Notice
S388 2018-03-28 30-day Notice
S387 2018-02-22 30-day Notice
S386 2018-02-12 Normal 180 Day Track
S385 2018-02-01 Real-time Process
S384 2017-12-14 Real-time Process
S383 2017-11-20 30-day Notice
S382 2017-10-20 30-day Notice
S381 2017-09-05 Real-time Process
S380 2017-09-01 Real-time Process
S379 2017-08-07 30-day Notice
S378 2017-07-21 Normal 180 Day Track
S377 2017-06-30 Real-time Process
S376 2017-06-28 30-day Notice
S375 2017-06-23 30-day Notice
S374 2017-05-18 Normal 180 Day Track
S373 2017-04-06 Real-time Process
S372 2016-12-15 Normal 180 Day Track
S371 2016-12-05 Real-time Process
S370 2016-11-28 30-day Notice
S369 2016-11-23 Real-time Process
S368 2016-11-16 Normal 180 Day Track
S367 2016-11-14 30-day Notice
S366 2016-10-05 30-day Notice
S365 2016-09-08 Real-time Process
S364 2016-09-06 30-day Notice
S363 2016-09-02 30-day Notice
S362 2016-07-15 30-day Notice
S361 2016-07-13 Real-time Process
S360 2016-06-27 Real-time Process
S359 2016-06-24 30-day Notice
S358 2016-06-24 Real-time Process
S357 2016-05-06 Real-time Process
S356 2016-05-03 Normal 180 Day Track
S355 2016-04-28 Real-time Process
S354 2016-04-15 Normal 180 Day Track
S353 2016-04-14 Real-time Process
S352 2016-03-18 Real-time Process
S351 2016-03-18 Real-time Process
S350 2016-03-17 Real-time Process
S349
S348 2015-12-28 30-day Notice
S347 2015-12-22 30-day Notice
S346 2015-12-18 Real-time Process
S345 2015-12-01 Normal 180 Day Track
S344 2015-11-16 Normal 180 Day Track
S343 2015-10-22 Real-time Process
S342 2015-10-22 Real-time Process
S341 2015-10-16 Real-time Process
S340 2015-10-14 30-day Notice
S339 2015-09-30 Normal 180 Day Track
S338 2015-09-24 Normal 180 Day Track
S337 2015-09-10 30-day Notice
S336 2015-08-28 Real-time Process
S335
S334 2015-07-31 Real-time Process
S333 2015-07-02 Real-time Process
S332
S331 2015-04-17 30-day Notice
S330 2015-04-14 Real-time Process
S329 2015-03-16 Normal 180 Day Track
S328 2015-03-06 Real-time Process
S327 2015-02-09 30-day Notice
S326 2014-12-22 Normal 180 Day Track
S325 2014-11-19 30-day Notice
S324 2014-10-14 30-day Notice
S323 2014-10-02 30-day Notice
S322 2014-09-29 30-day Notice
S321 2014-08-27 30-day Notice
S320 2014-08-27 Real-time Process
S319 2014-08-19 Real-time Process
S318 2014-08-15 Real-time Process
S317 2014-08-08 30-day Notice
S316 2014-08-06 30-day Notice
S315 2014-07-24 30-day Notice
S314 2014-07-24 Real-time Process
S313 2014-07-18 Normal 180 Day Track
S312 2014-07-14 30-day Notice
S311 2014-07-02 Real-time Process
S310 2014-06-06 30-day Notice
S309 2014-04-11 Normal 180 Day Track
S308 2014-04-01 30-day Notice
S307 2014-03-28 Real-time Process
S306 2014-03-28 Real-time Process
S305 2014-03-18 Real-time Process
S304 2014-03-05 Real-time Process
S303 2014-02-27 30-day Notice
S302 2014-01-29 30-day Notice
S301 2013-12-24 30-day Notice
S300 2013-12-23 30-day Notice
S299 2013-12-19 Real-time Process
S298 2013-12-19 30-day Notice
S297 2013-12-18 Normal 180 Day Track
S296 2013-12-17 30-day Notice
S295 2013-12-16 Normal 180 Day Track
S294 2013-12-13 30-day Notice
S293 2013-11-27 30-day Notice
S292 2013-11-12 Normal 180 Day Track No User Fee
S291 2013-10-30 30-day Notice
S290 2013-10-24 Real-time Process
S289 2013-10-24 30-day Notice
S288 2013-09-30 30-day Notice
S287 2013-09-17 30-day Notice
S286 2013-09-17 30-day Notice
S285 2013-08-23 Normal 180 Day Track
S284 2013-08-12 Real-time Process
S283 2013-08-06 Real-time Process
S282 2013-07-26 30-day Notice
S281 2013-07-10 Normal 180 Day Track No User Fee
S280 2013-07-08 Normal 180 Day Track
S279 2013-05-30 30-day Notice
S278 2013-05-17 Real-time Process
S277 2013-05-13 Real-time Process
S276 2013-05-10 30-day Notice
S275 2013-04-30 30-day Notice
S274
S273 2013-04-18 Real-time Process
S272 2013-04-10 Normal 180 Day Track No User Fee
S271 2013-03-22 30-day Notice
S270
S269 2013-02-26 Normal 180 Day Track
S268 2013-02-21 Normal 180 Day Track No User Fee
S267 2012-12-10 30-day Notice
S266 2012-11-21 30-day Notice
S265 2012-11-29 Normal 180 Day Track
S264 2012-10-19 30-day Notice
S263 2012-10-11 Real-time Process
S262 2012-09-26 30-day Notice
S261 2012-09-28 30-day Notice
S260 2012-09-13 Normal 180 Day Track
S259 2012-09-04 Normal 180 Day Track
S258 2012-08-24 Real-time Process
S257 2012-08-21 30-day Notice
S256 2012-08-13 30-day Notice
S255 2012-08-03 30-day Notice
S254 2012-07-17 Normal 180 Day Track
S253 2012-07-05 Normal 180 Day Track
S252 2012-06-29 Normal 180 Day Track
S251 2012-06-14 Normal 180 Day Track
S250 2012-06-11 30-day Notice
S249 2012-04-04 Real-time Process
S248 2012-03-07 30-day Notice
S247 2012-03-07 Normal 180 Day Track
S246 2012-02-29 30-day Notice
S245 2012-02-27 Real-time Process
S244
S243 2011-12-20 30-day Notice
S242 2011-11-25 Real-time Process
S241 2011-11-25 30-day Notice
S240 2011-11-21 Normal 180 Day Track
S239 2011-11-09 30-day Notice
S238 2011-11-04 Real-time Process
S237 2011-10-24 135 Review Track For 30-day Notice
S236 2011-09-22 30-day Notice
S235 2011-09-19 Real-time Process
S234 2011-07-18 30-day Notice
S233 2011-07-08 30-day Notice
S232 2011-07-06 30-day Notice
S231 2011-06-28 30-day Notice
S230 2011-06-08 30-day Notice
S229 2011-06-08 135 Review Track For 30-day Notice
S228 2011-05-25 Real-time Process
S227
S226 2011-05-19 Real-time Process
S225 2011-05-13 30-day Notice
S224 2011-05-10 30-day Notice
S223 2011-05-09 30-day Notice
S222
S221 2011-04-26 30-day Notice
S220 2011-03-29 Real-time Process
S219 2011-03-22 135 Review Track For 30-day Notice
S218 2011-03-18 135 Review Track For 30-day Notice
S217 2011-03-07 30-day Notice
S216 2011-02-28 30-day Notice
S215 2011-02-18 30-day Notice
S214 2011-02-09 Normal 180 Day Track
S213
S212 2011-01-25 30-day Notice
S211 2011-01-04 Normal 180 Day Track
S210 2010-12-23 Real-time Process
S209 2010-12-22 Normal 180 Day Track
S208 2010-11-23 30-day Notice
S207 2010-11-12 30-day Notice
S206 2010-10-26 30-day Notice
S205 2010-10-22 30-day Notice
S204 2010-10-12 30-day Notice
S203 2010-09-29 30-day Notice
S202
S201
S200 2010-09-09 30-day Notice
S199
S198 2010-07-15 30-day Notice
S197 2010-07-15 30-day Notice
S196 2010-07-15 30-day Notice
S195 2010-07-06 Real-time Process
S194 2010-06-28 135 Review Track For 30-day Notice
S193 2010-05-20 Real-time Process
S192 2010-05-17 Normal 180 Day Track
S191 2010-04-22 Normal 180 Day Track
S190 2010-04-15 30-day Notice
S189 2010-03-31 Normal 180 Day Track
S188 2010-03-31 Real-time Process
S187 2010-03-29 30-day Notice
S186 2010-03-01 Real-time Process
S185 2010-01-21 30-day Notice
S184 2010-01-19 30-day Notice
S183 2010-01-15 Real-time Process
S182 2010-01-13 30-day Notice
S181 2009-12-23 Normal 180 Day Track
S180 2009-12-18 30-day Notice
S179 2009-12-04 Normal 180 Day Track
S178 2009-11-17 Real-time Process
S177 2009-10-22 Normal 180 Day Track
S176 2009-10-09 30-day Notice
S175 2009-10-08 Real-time Process
S174 2009-09-08 30-day Notice
S173 2009-07-28 Real-time Process
S172 2009-06-17 Real-time Process
S171 2009-04-10 30-day Notice
S170
S169 2009-03-06 Normal 180 Day Track
S168 2009-03-02 Normal 180 Day Track
S167 2009-02-26 30-day Notice
S166 2009-02-23 Real-time Process
S165 2009-02-18 135 Review Track For 30-day Notice
S164 2009-02-09 135 Review Track For 30-day Notice
S163 2009-02-05 30-day Notice
S162 2008-12-22 Normal 180 Day Track No User Fee
S161 2008-12-15 30-day Notice
S160 2008-12-11 30-day Notice
S159 2008-12-11 30-day Notice
S158 2008-11-20 30-day Notice
S157
S156 2008-11-12 30-day Notice
S155 2008-11-07 Real-time Process
S154 2008-11-04 Normal 180 Day Track
S153 2008-11-03 30-day Notice
S152 2008-10-21 30-day Notice
S151 2008-10-17 Real-time Process
S150 2008-09-26 Real-time Process
S149
S148 2008-08-28 Real-time Process
S147
S146 2008-07-30 135 Review Track For 30-day Notice
S145 2008-07-28 Normal 180 Day Track
S144 2008-07-25 135 Review Track For 30-day Notice
S143 2008-06-27 135 Review Track For 30-day Notice
S142 2008-06-17 30-day Notice
S141 2008-06-13 Real-time Process
S140 2008-06-10 30-day Notice
S139 2008-04-14 30-day Notice
S138 2008-03-24 30-day Notice
S137 2008-03-21 30-day Notice
S136 2008-01-25 30-day Notice
S135
S134 2008-01-25 30-day Notice
S133 2007-12-07 30-day Notice
S132 2007-11-19 30-day Notice
S131 2007-10-31 Normal 180 Day Track
S130 2007-10-11 30-day Notice
S129 2007-09-28 Normal 180 Day Track
S128 2007-10-09 30-day Notice
S127 2007-09-24 Normal 180 Day Track No User Fee
S126 2007-08-23 Special (immediate Track)
S125 2007-08-14 Real-time Process
S124 2007-07-26 Real-time Process
S123 2007-06-15 Real-time Process
S122 2007-06-11 Real-time Process
S121 2007-05-18 30-day Notice
S120 2007-05-14 Real-time Process
S119 2007-05-10 Real-time Process
S118 2007-05-21 Real-time Process
S117 2007-03-09 Real-time Process
S116 2007-02-28 Real-time Process
S115 2006-12-20 Real-time Process
S114 2006-12-01 Normal 180 Day Track No User Fee
S113 2006-11-20 30-day Notice
S112 2006-10-31 Real-time Process
S111 2006-10-30 Normal 180 Day Track No User Fee
S110 2006-10-13 Real-time Process
S109 2006-10-03 Special (immediate Track)
S108 2006-08-21 Normal 180 Day Track No User Fee
S107 2006-07-21 Real-time Process
S106 2006-07-13 Real-time Process
S105 2006-06-19 Real-time Process
S104 2006-05-10 135 Review Track For 30-day Notice
S103 2006-04-10 Real-time Process
S102 2006-04-06 Real-time Process
S101 2006-02-21 Real-time Process
S100 2006-02-14 Real-time Process
S099 2006-02-01 Special (immediate Track)
S098 2005-12-22 Normal 180 Day Track No User Fee
S097 2005-12-09 Normal 180 Day Track
S096 2005-11-07 Real-time Process
S095 2005-10-19 Real-time Process
S094
S093 2005-10-07 Real-time Process
S092 2005-10-06 135 Review Track For 30-day Notice
S091 2005-10-05 Real-time Process
S090
S089 2005-09-16 Real-time Process
S088 2005-08-23 Real-time Process
S087 2005-06-06 Real-time Process
S086 2005-05-06 Normal 180 Day Track
S085 2005-05-05 Real-time Process
S084 2005-04-15 Normal 180 Day Track No User Fee
S083
S082 2005-01-31 Normal 180 Day Track
S081 2005-01-21 Real-time Process
S080 2004-12-06 Real-time Process
S079 2004-11-01 Normal 180 Day Track No User Fee
S078 2004-10-05 Real-time Process
S077 2004-09-20 Normal 180 Day Track
S076 2004-08-27 30-day Notice
S075 2004-08-23 Real-time Process
S074 2004-02-12 Real-time Process
S073 2003-11-28 Real-time Process
S072 2003-08-22 Normal 180 Day Track No User Fee
S071 2003-08-19 Real-time Process
S070
S069 2002-05-13 Real-time Process
S068 2001-10-15 Normal 180 Day Track
S067 2001-12-13 30-day Notice
S066 2001-11-13 Special (immediate Track)
S065 2001-09-14 Normal 180 Day Track
S064 2001-07-17 30-day Notice
S063 2001-04-11 Normal 180 Day Track
S062 2001-04-11 Real-time Process
S061 2000-08-02 Real-time Process
S060 2000-06-30 Real-time Process
S059
S058 1999-12-13 Real-time Process
S057 1998-06-12 30-day Notice
S056 1998-04-28 Real-time Process
S055 1998-04-20
S054 1998-04-03 Normal 180 Day Track
S053
S052 1997-08-18 Normal 180 Day Track
S051 1997-06-24 Normal 180 Day Track
S050 1997-05-05 Normal 180 Day Track
S049
S048 1996-10-22 Normal 180 Day Track
S047 1996-10-01 Normal 180 Day Track
S046 1996-05-20 Normal 180 Day Track
S045 1996-05-02 Normal 180 Day Track
S044 1996-03-14 Normal 180 Day Track
S043 1996-02-09 Normal 180 Day Track
S042 1995-08-16 Normal 180 Day Track
S041 1995-08-10 Normal 180 Day Track
S040 1995-04-26 Normal 180 Day Track
S039 1995-04-20 Normal 180 Day Track
S038 1995-04-11 Special (immediate Track)
S037 1995-04-06 Normal 180 Day Track
S036 1995-02-16 Normal 180 Day Track
S035 1994-12-22 Normal 180 Day Track
S034
S033 1994-10-11 Normal 180 Day Track
S032 1994-06-15 Normal 180 Day Track
S031 1994-05-23 Normal 180 Day Track
S030 1994-03-18 Normal 180 Day Track
S029 1994-03-17 Normal 180 Day Track
S028 1994-02-16 Normal 180 Day Track
S027 1994-02-10 Normal 180 Day Track
S026
S025 1994-01-04 Normal 180 Day Track
S024 1993-12-29 Normal 180 Day Track
S023 1993-06-21 Normal 180 Day Track
S022 1993-06-14 Normal 180 Day Track
S021 1993-04-07 Normal 180 Day Track
S020 1992-12-08 Normal 180 Day Track
S019 1992-07-20 Normal 180 Day Track
S018 1992-07-13 Normal 180 Day Track
S017 1992-07-10 Normal 180 Day Track
S016 1992-03-26 Normal 180 Day Track
S015 1992-03-26 Normal 180 Day Track
S014 1992-03-26 Normal 180 Day Track
S013 1991-11-22 Normal 180 Day Track
S012 1991-10-16 Normal 180 Day Track
S011 1991-09-30 Normal 180 Day Track
S010 1991-08-09 Normal 180 Day Track
S009 1991-08-02 Normal 180 Day Track
S008 1991-07-23 Normal 180 Day Track
S007 1991-05-10 Normal 180 Day Track
S006 1991-01-14 Normal 180 Day Track
S005 1990-10-30 Normal 180 Day Track
S004 1990-08-24 Normal 180 Day Track
S003 1990-08-10 Normal 180 Day Track
S002 1989-11-30 Normal 180 Day Track
S001 1989-09-29 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00721902438400 P890003 000
00721902438400 P890003 000
00681490501880 P890003 027
00681490501880 P890003 027
00681490207256 P890003 046
00681490207256 P890003 046
00613994250155 P890003 050
00613994250148 P890003 050
00885074201573 P890003 050
00885074201566 P890003 050
00681490122931 P890003 050
00681490122832 P890003 050
00613994250148 P890003 050
00681490122733 P890003 050
00681490122733 P890003 050
00681490122931 P890003 050
00613994250155 P890003 050
00681490122832 P890003 050
00721902046940 P890003 063
00721902046940 P890003 063
00721902307317 P890003 065
00721902307294 P890003 065
00721902307300 P890003 065
00721902546655 P890003 065
00721902710322 P890003 065
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00721902283802 P890003 065
00681490132558 P890003 065
10681490142653 P890003 065
00721902546655 P890003 065
00721902290138 P890003 065
00721902290121 P890003 065
00721902256011 P890003 065
00721902283819 P890003 065
00721902290121 P890003 065
00721902290138 P890003 065
00721902307294 P890003 065
00721902307300 P890003 065
00721902307317 P890003 065
00721902710322 P890003 065
00721902710346 P890003 065
00721902710353 P890003 065
00721902824692 P890003 065
00643169431850 P890003 065
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00721902256011 P890003 065
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10681490142653 P890003 065
00613994362896 P890003 065
00613994175403 P890003 065
00643169431850 P890003 065
00721902710353 P890003 065
00613994521750 P890003 065
00613994175403 P890003 065
00613994362896 P890003 065
00613994435125 P890003 065
00613994521750 P890003 065
00613994175397 P890003 065
00613994127631 P890003 065
00613994127631 P890003 065
00613994175397 P890003 065
00613994435125 P890003 065
00885074301440 P890003 080
00885074301440 P890003 080
00613994119995 P890003 097
00613994119995 P890003 097
00721902309564 P890003 098
00721902309564 P890003 098
00721902309588 P890003 098
00721902309588 P890003 098
00643169102101 P890003 110
00613994910387 P890003 110
00643169102101 P890003 110
00643169312913 P890003 110
00613994910387 P890003 110
00643169312913 P890003 110
00613994381071 P890003 127
00613994381071 P890003 127
00613994434937 P890003 145
00613994434937 P890003 145
00613994581570 P890003 151
00613994581570 P890003 151
00613994501011 P890003 162
00763000059477 P890003 162
00613994501011 P890003 162
00763000059477 P890003 162
00613994581594 P890003 172
00613994581594 P890003 172
00613994952400 P890003 228
00613994952431 P890003 228
00643169192058 P890003 228
00613994952431 P890003 228
00643169341074 P890003 228
00613994952400 P890003 228
00643169192058 P890003 228
00643169341074 P890003 228
00643169102095 P890003 238
00643169102095 P890003 238
00643169191815 P890003 253
00643169312098 P890003 253
00643169191815 P890003 253
00643169312098 P890003 253
00613994909688 P890003 254
00613994909565 P890003 254
00613994909565 P890003 254
00643169369030 P890003 254
00613994909688 P890003 254
00643169369030 P890003 254
00643169107052 P890003 258
00643169107052 P890003 258
00643169334717 P890003 258
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00643169341050 P890003 258
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00643169703223 P890003 260
00613994524232 P890003 260
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00643169703193 P890003 260
00643169703193 P890003 260
00613994524232 P890003 260
00643169469891 P890003 269
00643169486744 P890003 269
00643169469891 P890003 269
00643169486744 P890003 269
00643169341067 P890003 284
00643169341067 P890003 284
00643169402904 P890003 284
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00643169441101 P890003 285
00643169441101 P890003 285
00643169325715 P890003 290
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00643169325685 P890003 290
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00643169325708 P890003 290
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00643169459885 P890003 297
00643169460089 P890003 297
00643169460089 P890003 297
00643169459885 P890003 297
00643169367203 P890003 299
00643169367203 P890003 299
00643169452060 P890003 306
00643169452060 P890003 306
00643169469884 P890003 307
00643169469884 P890003 307
00643169527539 P890003 313
00643169527539 P890003 313
00643169838604 P890003 314
00643169838604 P890003 314
00643169703247 P890003 314
00643169431874 P890003 314
00643169703247 P890003 314
00643169431874 P890003 314
00643169312081 P890003 319
00643169312081 P890003 319
00643169552289 P890003 320
00643169552289 P890003 320
00643169552104 P890003 320
00643169552104 P890003 320
00643169569744 P890003 328
00643169569744 P890003 328
00643169666320 P890003 328
00643169666320 P890003 328
00643169376823 P890003 329
00643169376823 P890003 329
00643169705746 P890003 334
00643169705753 P890003 334
00643169705753 P890003 334
00643169705746 P890003 334
00643169658127 P890003 342
00643169657885 P890003 342
00643169658127 P890003 342
00643169657885 P890003 342
00643169690943 P890003 343
00643169690943 P890003 343
00643169545526 P890003 345
00643169545526 P890003 345
00643169658134 P890003 351
00643169658134 P890003 351
00643169763548 P890003 360
00643169763548 P890003 360
00643169636668 P890003 361
00643169636668 P890003 361
00643169725386 P890003 369
00643169947115 P890003 369
00643169725195 P890003 369
00643169725362 P890003 369
00643169725386 P890003 369
00643169947115 P890003 369
00643169725379 P890003 369
00643169725379 P890003 369
00643169725195 P890003 369
00643169725379 P890003 369
00643169725362 P890003 369
00763000014384 P890003 374
00763000014384 P890003 374
00643169957657 P890003 386
00763000201289 P890003 386
00763000033217 P890003 390
00763000113988 P890003 390
00763000033194 P890003 390
00763000114015 P890003 390
00763000114015 P890003 390
00763000113797 P890003 390
00763000114008 P890003 390
00763000113797 P890003 390
00763000113995 P890003 390
00763000113995 P890003 390
00763000114008 P890003 390
00643169552043 P890003 390

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