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.
Approval for the use of an alternative bead blasted shield surface finish long with an associated change to the laser engraving for the medtronic synchromed pump's titanium shields. The bead blasted shield finish, and associated continuous laser power engraving process, may serve as an alternative to the current straight line shield finish in that either finish may be used on the device.
| Device | MEDTRONIC SYNCHROMED INFUSION SYSTEM |
| Classification Name | Pump, Infusion, Implanted, Programmable |
| Generic Name | Pump, Infusion, Implanted, Programmable |
| Applicant | MEDTRONIC Inc. |
| Date Received | 1997-02-27 |
| Decision Date | 1997-07-17 |
| PMA | P860004 |
| Supplement | S036 |
| Product Code | LKK |
| Advisory Committee | General Hospital |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDTRONIC Inc. 7000 Central Avenue Ne minneapolis, MN 55432-3576 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P860004 | Original 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 |