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 following changes involving the motor coil for the synchromed ii implantable infusion pump: 1) change from a crimped to a heat-welded motor coil connector pin; and 2) change to a silicon varnish surface coating of the motor coil, the same coating as applied to the motor coil of the synchromed el implantable infusion pump.
| Device | SYNCHROMED II PROGRAMMABLE DRUG INFUSION SYSTEM |
| Classification Name | Pump, Infusion, Implanted, Programmable |
| Generic Name | Pump, Infusion, Implanted, Programmable |
| Applicant | MEDTRONIC Inc. |
| Date Received | 2004-03-24 |
| Decision Date | 2004-03-29 |
| PMA | P860004 |
| Supplement | S060 |
| Product Code | LKK |
| Advisory Committee | General Hospital |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |