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 of the following manufacturing process changes related to the baseline test of the implantable synchromed ii infusion pump, model 8637: 1) automation of the transfer of baseline test data; 2) change the duty cycle and lower the specification limit of the dynamic current test; and 3) an increase to the time to measure the micro awake current.
| Device | SYNCHROMED II INFUSION SYSTEM |
| Classification Name | Pump, Infusion, Implanted, Programmable |
| Generic Name | Pump, Infusion, Implanted, Programmable |
| Applicant | MEDTRONIC Inc. |
| Date Received | 2010-08-10 |
| Decision Date | 2011-03-03 |
| PMA | P860004 |
| Supplement | S138 |
| Product Code | LKK |
| Advisory Committee | General Hospital |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| 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 |