SYNCHROMED(TM) INFUSION SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Premarket Approval P860004 S005

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

DeviceSYNCHROMED(TM) INFUSION SYSTEM
Classification NamePump, Infusion, Implanted, Programmable
Generic NamePump, Infusion, Implanted, Programmable
ApplicantMEDTRONIC Inc.
Date Received1988-09-01
Decision Date1989-01-11
PMAP860004
SupplementS005
Product CodeLKK
Advisory CommitteeGeneral Hospital
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address MEDTRONIC Inc. 7000 Central Avenue Ne minneapolis, MN 55432-3576

Supplemental Filings

Supplement NumberDateSupplement Type
P860004Original Filing
S403 2022-11-23 30-day Notice
S402 2022-11-07 30-day Notice
S401 2022-10-20 30-day Notice
S400 2022-09-30 30-day Notice
S399 2022-08-29 30-day Notice
S398 2022-08-24 30-day Notice
S397 2022-08-19 Special (immediate Track)
S396 2022-08-10 30-day Notice
S395 2022-07-22 Special (immediate Track)
S394 2022-07-20 30-day Notice
S393 2022-05-20 30-day Notice
S392
S391 2022-05-03 30-day Notice
S390 2022-05-03 30-day Notice
S389 2022-04-08 30-day Notice
S388 2022-03-02 30-day Notice
S387
S386 2022-01-28 30-day Notice
S385
S384
S383 2021-11-15 30-day Notice
S382 2021-11-04 30-day Notice
S381 2021-09-30 30-day Notice
S380
S379
S378
S377 2021-07-14 Real-time Process
S376 2021-06-21 30-day Notice
S375 2021-05-28 30-day Notice
S374 2021-05-04 30-day Notice
S373 2021-04-09 30-day Notice
S372 2021-04-08 30-day Notice
S371 2021-03-08 30-day Notice
S370 2021-03-05 30-day Notice
S369 2021-02-25 30-day Notice
S368
S367 2020-12-11 30-day Notice
S366 2020-11-18 30-day Notice
S365 2020-11-03 30-day Notice
S364 2020-10-20 30-day Notice
S363 2020-08-26 Real-time Process
S362 2020-08-11 30-day Notice
S361
S360
S359 2020-05-11 30-day Notice
S358 2020-04-24 30-day Notice
S357 2020-04-16 30-day Notice
S356 2020-04-09 30-day Notice
S355 2020-03-23 30-day Notice
S354 2020-03-11 30-day Notice
S353 2020-03-09 30-day Notice
S352
S351 2019-12-23 Special (immediate Track)
S350 2019-12-10 30-day Notice
S349 2019-12-10 30-day Notice
S348 2019-11-25 30-day Notice
S347 2019-11-15 30-day Notice
S346
S345
S344 2019-09-27 30-day Notice
S343 2019-09-16 30-day Notice
S342 2019-09-06 30-day Notice
S341 2019-08-30 30-day Notice
S340
S339 2019-08-09 30-day Notice
S338
S337 2019-07-26 30-day Notice
S336
S335 2019-07-16 30-day Notice
S334
S333 2019-06-06 30-day Notice
S332 2019-05-06 30-day Notice
S331 2019-04-26 30-day Notice
S330
S329 2019-04-01 30-day Notice
S328 2019-03-21 Special (immediate Track)
S327 2019-03-07 30-day Notice
S326 2019-02-27 30-day Notice
S325
S324 2018-12-26 Real-time Process
S323 2018-12-17 30-day Notice
S322 2018-12-11 30-day Notice
S321 2018-11-14 Real-time Process
S320 2018-10-30 30-day Notice
S319 2018-10-23 Real-time Process
S318 2018-10-19 30-day Notice
S317 2018-09-13 30-day Notice
S316
S315 2018-07-17 30-day Notice
S314 2018-07-02 30-day Notice
S313 2018-07-02 30-day Notice
S312 2018-06-18 30-day Notice
S311 2018-06-01 Real-time Process
S310 2018-05-24 30-day Notice
S309 2018-05-16 30-day Notice
S308 2018-05-07 30-day Notice
S307 2018-05-07 30-day Notice
S306 2018-05-02 30-day Notice
S305 2018-04-26 30-day Notice
S304 2018-04-24 30-day Notice
S303 2018-04-16 30-day Notice
S302 2018-03-30 30-day Notice
S301 2018-03-26 30-day Notice
S300 2018-03-19 Real-time Process
S299 2018-03-12 30-day Notice
S298 2018-01-30 30-day Notice
S297 2018-01-25 Real-time Process
S296 2017-12-18 30-day Notice
S295 2017-12-18 30-day Notice
S294 2017-12-11 Normal 180 Day Track No User Fee
S293 2017-11-24 30-day Notice
S292 2017-11-20 30-day Notice
S291 2017-10-30 Normal 180 Day Track
S290 2017-09-05 Normal 180 Day Track No User Fee
S289 2017-08-22 135 Review Track For 30-day Notice
S288 2017-08-04 30-day Notice
S287 2017-07-28 30-day Notice
S286 2017-07-24 30-day Notice
S285 2017-07-17 30-day Notice
S284 2017-07-17 Real-time Process
S283 2017-07-17 30-day Notice
S282 2017-06-26 30-day Notice
S281 2017-06-08 Normal 180 Day Track
S280 2017-06-07 30-day Notice
S279 2017-05-22 30-day Notice
S278 2017-05-01 30-day Notice
S277 2017-04-28 30-day Notice
S276 2017-04-27 30-day Notice
S275 2017-04-27 Normal 180 Day Track
S274 2017-04-26 30-day Notice
S273
S272 2017-04-03 30-day Notice
S271 2017-03-15 Normal 180 Day Track
S270 2017-03-14 Special (immediate Track)
S269 2017-02-06 30-day Notice
S268 2017-02-03 Normal 180 Day Track
S267 2017-01-27 30-day Notice
S266 2016-12-16 30-day Notice
S265 2016-12-06 30-day Notice
S264 2016-11-21 Special (immediate Track)
S263 2016-11-14 30-day Notice
S262 2016-10-31 Normal 180 Day Track
S261 2016-10-28 Normal 180 Day Track
S260 2016-08-12 30-day Notice
S259 2016-08-01 30-day Notice
S258 2016-07-25 30-day Notice
S257 2016-06-30 Real-time Process
S256 2016-06-28 30-day Notice
S255 2016-06-27 30-day Notice
S254 2016-06-27 30-day Notice
S253 2016-06-09 30-day Notice
S252 2016-06-09 30-day Notice
S251 2016-06-07 30-day Notice
S250 2016-05-31 Real-time Process
S249 2016-04-13 30-day Notice
S248 2016-04-05 30-day Notice
S247 2016-03-04 30-day Notice
S246 2016-02-08 Normal 180 Day Track
S245 2016-01-19 30-day Notice
S244 2015-12-11 30-day Notice
S243 2015-11-10 Normal 180 Day Track
S242 2015-10-29 30-day Notice
S241 2015-10-21 30-day Notice
S240 2015-10-13 30-day Notice
S239 2015-10-06 30-day Notice
S238 2015-09-30 30-day Notice
S237 2015-09-22 30-day Notice
S236 2015-08-31 135 Review Track For 30-day Notice
S235 2015-08-17 135 Review Track For 30-day Notice
S234 2015-07-20 30-day Notice
S233
S232 2015-06-18 30-day Notice
S231 2015-06-17 30-day Notice
S230 2015-06-01 30-day Notice
S229 2015-05-29 30-day Notice
S228 2015-05-28 30-day Notice
S227 2015-04-28 30-day Notice
S226 2015-03-19 30-day Notice
S225 2015-03-06 30-day Notice
S224 2015-03-02 Normal 180 Day Track
S223 2015-02-27 30-day Notice
S222 2015-02-04 30-day Notice
S221 2015-02-02 30-day Notice
S220 2015-01-12 30-day Notice
S219 2015-01-09 30-day Notice
S218 2015-01-09 30-day Notice
S217 2014-11-03 Normal 180 Day Track
S216 2014-10-27 30-day Notice
S215 2014-09-19 30-day Notice
S214 2014-09-16 30-day Notice
S213 2014-09-04 30-day Notice
S212 2014-08-25 30-day Notice
S211 2014-08-15 30-day Notice
S210 2014-07-15 Special (immediate Track)
S209 2014-06-25 30-day Notice
S208 2014-06-04 30-day Notice
S207 2014-05-30 30-day Notice
S206 2014-05-12 Normal 180 Day Track
S205 2014-05-12 Real-time Process
S204 2014-03-28 30-day Notice
S203 2014-03-13 30-day Notice
S202 2014-01-28 Special (immediate Track)
S201 2013-11-19 30-day Notice
S200 2013-09-30 30-day Notice
S199 2013-09-30 30-day Notice
S198 2013-09-24 30-day Notice
S197 2013-09-23 30-day Notice
S196 2013-09-23 30-day Notice
S195 2013-09-13 30-day Notice
S194 2013-07-29 30-day Notice
S193 2013-07-15 30-day Notice
S192 2013-07-12 30-day Notice
S191 2013-04-25 Special (immediate Track)
S190 2013-03-18 30-day Notice
S189 2013-04-17 Real-time Process
S188 2013-02-22 30-day Notice
S187 2013-02-07 Real-time Process
S186 2013-02-01 30-day Notice
S185 2012-12-19 Normal 180 Day Track
S184 2012-12-14 Normal 180 Day Track
S183
S182 2012-12-11 30-day Notice
S181 2012-12-11 30-day Notice
S180 2012-11-30 Real-time Process
S179 2012-11-21 Special (immediate Track)
S178 2012-11-14 30-day Notice
S177 2012-10-05 Real-time Process
S176 2012-10-04 30-day Notice
S175 2012-08-28 Real-time Process
S174 2012-07-26 30-day Notice
S173 2012-07-26 30-day Notice
S172
S171 2012-05-24 30-day Notice
S170 2012-05-11 30-day Notice
S169 2012-05-09 30-day Notice
S168 2012-05-07 30-day Notice
S167 2011-12-27 Real-time Process
S166 2011-12-08 30-day Notice
S165
S164 2011-11-08 30-day Notice
S163 2011-11-07 Normal 180 Day Track No User Fee
S162 2011-11-04 30-day Notice
S161 2011-10-14 135 Review Track For 30-day Notice
S160 2011-10-11 30-day Notice
S159 2011-09-23 Real-time Process
S158 2011-09-26 Real-time Process
S157 2011-07-29 Special (immediate Track)
S156 2011-07-22 30-day Notice
S155 2011-07-19 30-day Notice
S154 2011-06-29 30-day Notice
S153 2011-06-10 30-day Notice
S152 2011-05-18 30-day Notice
S151 2011-05-13 135 Review Track For 30-day Notice
S150 2011-04-18 135 Review Track For 30-day Notice
S149 2011-03-16 135 Review Track For 30-day Notice
S148 2011-02-28 30-day Notice
S147 2011-02-25 Normal 180 Day Track No User Fee
S146 2011-02-07 30-day Notice
S145 2010-12-08 30-day Notice
S144 2010-12-07 30-day Notice
S143 2010-10-25 30-day Notice
S142 2010-10-14 30-day Notice
S141
S140 2010-09-07 Special (immediate Track)
S139 2010-08-31 30-day Notice
S138 2010-08-10 135 Review Track For 30-day Notice
S137 2010-08-09 30-day Notice
S136 2010-07-08 Real-time Process
S135 2010-06-30 30-day Notice
S134 2010-06-28 30-day Notice
S133 2010-06-28 135 Review Track For 30-day Notice
S132 2010-06-01 30-day Notice
S131 2010-05-28 30-day Notice
S130 2010-05-26 Normal 180 Day Track
S129 2010-05-25 Normal 180 Day Track No User Fee
S128 2010-05-06 Normal 180 Day Track
S127 2010-04-20 30-day Notice
S126 2010-04-20 Special (immediate Track)
S125 2010-04-19 Normal 180 Day Track
S124 2010-03-19 30-day Notice
S123 2010-03-19 Real-time Process
S122 2010-02-05 30-day Notice
S121 2010-02-01 30-day Notice
S120 2010-01-28 Special (immediate Track)
S119 2010-01-27 30-day Notice
S118 2010-01-06 Real-time Process
S117 2010-01-07 Real-time Process
S116 2009-11-10 Special (immediate Track)
S115 2009-10-26 30-day Notice
S114 2009-10-01 Special (immediate Track)
S113
S112 2009-08-21 30-day Notice
S111 2009-08-10 30-day Notice
S110 2009-07-21 30-day Notice
S109 2009-07-09 Special (immediate Track)
S108 2009-07-02 Real-time Process
S107 2009-04-02 30-day Notice
S106 2009-03-20 30-day Notice
S105 2009-03-02 30-day Notice
S104 2009-01-12 Real-time Process
S103 2008-12-15 30-day Notice
S102 2008-11-28 Special (immediate Track)
S101 2008-09-02 30-day Notice
S100 2008-08-04 Special (immediate Track)
S099 2008-07-24 135 Review Track For 30-day Notice
S098 2008-03-11 30-day Notice
S097 2008-03-10 135 Review Track For 30-day Notice
S096 2008-02-25 30-day Notice
S095 2007-11-23 30-day Notice
S094 2007-10-18 Real-time Process
S093
S092 2007-08-31 Real-time Process
S091 2007-08-20 Special (immediate Track)
S090 2007-06-22 Normal 180 Day Track
S089 2007-03-12 Normal 180 Day Track
S088 2006-11-08 Real-time Process
S087 2006-05-17 135 Review Track For 30-day Notice
S086
S085
S084 2006-05-08 Special (immediate Track)
S083 2006-05-01 Real-time Process
S082 2006-03-15 Real-time Process
S081 2006-01-13 Real-time Process
S080 2005-12-12 Special (immediate Track)
S079 2005-12-02 Normal 180 Day Track
S078 2005-11-23 Real-time Process
S077 2005-09-30 Real-time Process
S076 2005-09-27 Normal 180 Day Track No User Fee
S075 2005-09-16 Real-time Process
S074 2005-08-12 135 Review Track For 30-day Notice
S073 2005-06-24 30-day Notice
S072 2005-06-22 30-day Notice
S071 2005-04-05 30-day Notice
S070 2005-03-31 Normal 180 Day Track
S069 2005-03-08 Real-time Process
S068 2005-02-07 Special (immediate Track)
S067 2005-01-31 Special (immediate Track)
S066 2005-01-21 Normal 180 Day Track
S065 2004-12-16 Real-time Process
S064 2004-12-16 Real-time Process
S063 2004-10-19 30-day Notice
S062
S061 2004-05-19 Special (immediate Track)
S060 2004-03-24 Real-time Process
S059 2004-02-23 Real-time Process
S058 2004-01-15 Normal 180 Day Track
S057 2003-11-03 Real-time Process
S056 2003-04-07 Normal 180 Day Track
S055 2002-11-29 Real-time Process
S054 2002-09-16 Real-time Process
S053 2002-09-13 Special (immediate Track)
S052 2002-05-07 Normal 180 Day Track
S051 2002-04-29 Real-time Process
S050 2002-04-23 Real-time Process
S049
S048 2001-11-05 Special (immediate Track)
S047 2001-07-05 Special (immediate Track)
S046 2001-06-18 Real-time Process
S045 2000-03-29 Real-time Process
S044
S043 1999-10-18 Real-time Process
S042 1999-02-26 Real-time Process
S041 1998-11-09 Real-time Process
S040 1998-01-15 Normal 180 Day Track
S039 1997-11-25 Normal 180 Day Track
S038 1997-05-28 Special (immediate Track)
S037 1997-02-28 Normal 180 Day Track
S036 1997-02-27 Normal 180 Day Track
S035 1996-05-08 Normal 180 Day Track
S034 1995-04-24 Normal 180 Day Track
S033 1995-04-20 Special (immediate Track)
S032 1994-03-30 Normal 180 Day Track
S031 1993-09-07 Normal 180 Day Track
S030 1993-05-17 Normal 180 Day Track
S029 1993-01-21 Normal 180 Day Track
S028 1992-11-13 Normal 180 Day Track
S027 1992-07-09 Normal 180 Day Track
S026 1992-06-05 Normal 180 Day Track
S025
S024 1992-01-03 Normal 180 Day Track
S023 1991-10-04 Normal 180 Day Track
S022 1991-09-13 Normal 180 Day Track
S021
S020 1991-08-29 Normal 180 Day Track
S019 1991-06-20 Normal 180 Day Track
S018
S017 1991-04-19 Normal 180 Day Track
S016 1990-05-09 Normal 180 Day Track
S015
S014 1989-12-28 Normal 180 Day Track
S013 1989-09-25 Normal 180 Day Track
S012 1989-08-04 Normal 180 Day Track
S011 1989-07-31 Normal 180 Day Track
S010 1989-04-10 Normal 180 Day Track
S009
S008 1988-11-08 Normal 180 Day Track
S007 1988-10-27 Normal 180 Day Track
S006 1988-09-23 Normal 180 Day Track
S005 1988-09-01 Special (immediate Track)
S004 1988-06-03 Normal 180 Day Track
S003 1988-05-19 Normal 180 Day Track
S002 1988-03-29 Normal 180 Day Track
S001 1987-03-30 Panel Track

NIH GUDID Devices

Device IDPMASupp
00673978940212 P860004 000
10681490185186 P860004 000
00643169012448 P860004 029
00721902169120 P860004 046
00613994997937 P860004 052
00721902620898 P860004 054
00721902625985 P860004 054
00613994533579 P860004 058
00613994338754 P860004 089
00643169512948 P860004 089
00763000875701 P860004 089
00763000875695 P860004 089
00613994647115 P860004 104
00613994586032 P860004 120
00613994586087 P860004 120
00643169202139 P860004 125
00643169202146 P860004 125
00643169202153 P860004 125
00643169202122 P860004 125
00613994408495 P860004 125
00613994555618 P860004 125
00613994555625 P860004 125
00613994555601 P860004 125
00613994555595 P860004 125
00613994555632 P860004 125
00613994555649 P860004 125
00613994586056 P860004 128
00613994779229 P860004 130
00613994586070 P860004 147
00643169158115 P860004 167
00643169158092 P860004 167
00643169158085 P860004 167
00643169158108 P860004 167
00643169496040 P860004 179
00643169496057 P860004 179
00643169496033 P860004 179
00643169100831 P860004 179
00643169100824 P860004 179
00643169100794 P860004 179
00643169100879 P860004 179
00643169100978 P860004 179
00643169101067 P860004 179
00643169101081 P860004 179
00643169496026 P860004 179
00643169100954 P860004 191
00643169396968 P860004 205
00643169518957 P860004 206
00643169508156 P860004 224
00643169508149 P860004 224
00643169640863 P860004 243
00643169783034 P860004 250
00643169783027 P860004 250
00643169561601 P860004 250
00643169359154 P860004 250
00643169359178 P860004 257
00643169530119 P860004 261
00643169530126 P860004 261
00643169699953 P860004 262
00643169699946 P860004 262
00643169887619 P860004 263
00643169887602 P860004 263
00643169887596 P860004 263
00643169630505 P860004 268
00643169630512 P860004 268
00643169984226 P860004 270
00643169887633 P860004 270
00643169887640 P860004 270
00643169984219 P860004 270
00643169887657 P860004 278
00643169887664 P860004 278
00643169974791 P860004 281
00643169771031 P860004 281
00763000004095 P860004 291
00643169771048 P860004 291
00763000051143 P860004 294
00763000051136 P860004 294
00763000051129 P860004 294
00763000051112 P860004 294
00763000051150 P860004 294
00763000051174 P860004 294
00763000051167 P860004 294
00763000232405 P860004 320
00763000232412 P860004 320
00763000232429 P860004 320
00763000301354 P860004 361
00763000301361 P860004 361
00763000422608 P860004 369
00763000422615 P860004 369
00763000634094 P860004 378
00763000634100 P860004 378
00763000634100 P860004 380
00763000634094 P860004 380
00763000631482 P860004 384
00763000632786 P860004 404
00763000632793 P860004 404
00763000597023 P860004 404
00763000597030 P860004 404
00763000745073 P860004 404
00763000916633 P860004 406
00763000916671 P860004 406
00763000916664 P860004 406
00763000916657 P860004 406
00763000916640 P860004 406
00763000825539 P860004 415
00763000852610 P860004 415
00763000825515 P860004 415
00763000852597 P860004 415
00763000852603 P860004 415
00763000852627 P860004 415
00763000852634 P860004 415
00763000825522 P860004 415
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