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 a labeling update that modifies your deep brain stimulation (dbs) therapy information for prescriber¿s and the dbs patient therapy guide. The labeling update is to modify two precautions that appear in each manual:1) remove the precaution on potential release of neurotoxic and carcinogenic compounds from polyurethane lead materials; and2) modify the precaution on long-term safety of multiple leads and replacement leads to read: the long-term safety associated with implanting more than one lead on the same side of the brain is unknown.
Device | IMPLANTABLE MULTI-PROGRAMMABLE QUADRIPOLAR DEEP BRAIN STIMULATION SYSTEM |
Classification Name | Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Generic Name | Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Applicant | MEDTRONIC Inc. |
Date Received | 2013-03-18 |
Decision Date | 2015-06-22 |
PMA | P960009 |
Supplement | S169 |
Product Code | MHY |
Advisory Committee | Neurology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Pas |
Expedited Review | No |
Combination Product | No |
Applicant Address | MEDTRONIC Inc. 7000 Central Avenue Ne minneapolis, MN 55432-3576 |
Supplement Number | Date | Supplement Type |
---|---|---|
P960009 | Original Filing | |
S446 | 2023-01-20 | 30-day Notice |
S445 | ||
S444 | 2022-11-23 | 30-day Notice |
S443 | 2022-11-14 | 30-day Notice |
S442 | 2022-11-08 | 30-day Notice |
S441 | 2022-10-18 | 30-day Notice |
S440 | 2022-10-12 | 30-day Notice |
S439 | 2022-09-07 | 30-day Notice |
S438 | ||
S437 | 2022-08-10 | 30-day Notice |
S436 | 2022-08-04 | 30-day Notice |
S435 | 2022-07-20 | 30-day Notice |
S434 | ||
S433 | ||
S432 | 2022-05-26 | 30-day Notice |
S431 | 2022-05-20 | 30-day Notice |
S430 | ||
S429 | 2022-05-12 | 30-day Notice |
S428 | 2022-05-11 | 30-day Notice |
S427 | 2022-05-11 | 30-day Notice |
S426 | 2022-05-03 | 30-day Notice |
S425 | 2022-05-03 | 30-day Notice |
S424 | ||
S423 | 2022-03-02 | 30-day Notice |
S422 | 2022-02-24 | Normal 180 Day Track No User Fee |
S421 | 2022-02-15 | 30-day Notice |
S420 | ||
S419 | ||
S418 | ||
S417 | ||
S416 | 2021-12-20 | 30-day Notice |
S415 | ||
S414 | 2021-11-15 | 30-day Notice |
S413 | 2021-11-04 | 30-day Notice |
S412 | 2021-10-06 | 30-day Notice |
S411 | 2021-10-01 | 30-day Notice |
S410 | 2021-09-27 | 30-day Notice |
S409 | ||
S408 | ||
S407 | 2021-08-11 | 30-day Notice |
S406 | 2021-08-03 | 30-day Notice |
S405 | 2021-07-23 | 30-day Notice |
S404 | 2021-07-14 | 30-day Notice |
S403 | 2021-07-02 | 30-day Notice |
S402 | 2021-06-21 | 30-day Notice |
S401 | 2021-05-28 | 30-day Notice |
S400 | ||
S399 | 2021-03-08 | 30-day Notice |
S398 | 2021-03-05 | 30-day Notice |
S397 | ||
S396 | ||
S395 | 2021-01-11 | 30-day Notice |
S394 | 2020-12-18 | Special (immediate Track) |
S393 | 2020-12-16 | 30-day Notice |
S392 | 2020-12-11 | 30-day Notice |
S391 | ||
S390 | 2020-11-18 | 30-day Notice |
S389 | 2020-10-20 | 30-day Notice |
S388 | 2020-10-20 | 30-day Notice |
S387 | 2020-10-15 | 30-day Notice |
S386 | 2020-10-15 | 30-day Notice |
S385 | ||
S384 | 2020-09-03 | 30-day Notice |
S383 | ||
S382 | ||
S381 | 2020-08-12 | 30-day Notice |
S380 | 2020-08-11 | 30-day Notice |
S379 | 2020-08-07 | 30-day Notice |
S378 | 2020-08-04 | Special (immediate Track) |
S377 | ||
S376 | ||
S375 | 2020-05-11 | 30-day Notice |
S374 | 2020-04-09 | 30-day Notice |
S373 | 2020-04-09 | 30-day Notice |
S372 | 2020-03-23 | 30-day Notice |
S371 | 2020-03-11 | 30-day Notice |
S370 | 2020-02-28 | 30-day Notice |
S369 | 2020-02-19 | 30-day Notice |
S368 | 2020-01-07 | 30-day Notice |
S367 | 2019-12-10 | 30-day Notice |
S366 | 2019-12-10 | 30-day Notice |
S365 | ||
S364 | 2019-11-20 | 30-day Notice |
S363 | ||
S362 | 2019-11-15 | 30-day Notice |
S361 | ||
S360 | 2019-09-27 | 30-day Notice |
S359 | 2019-09-16 | 30-day Notice |
S358 | 2019-08-19 | 30-day Notice |
S357 | 2019-08-05 | Special (immediate Track) |
S356 | 2019-07-29 | 30-day Notice |
S355 | ||
S354 | 2019-07-16 | 30-day Notice |
S353 | 2019-07-01 | 30-day Notice |
S352 | 2019-06-06 | 30-day Notice |
S351 | ||
S350 | 2019-05-06 | 30-day Notice |
S349 | 2019-04-30 | 30-day Notice |
S348 | 2019-04-26 | 30-day Notice |
S347 | ||
S346 | 2019-04-05 | 30-day Notice |
S345 | 2019-04-01 | 30-day Notice |
S344 | 2019-03-21 | Special (immediate Track) |
S343 | 2019-03-07 | 30-day Notice |
S342 | 2019-03-04 | 30-day Notice |
S341 | ||
S340 | 2019-02-21 | 30-day Notice |
S339 | 2019-02-14 | Real-time Process |
S338 | 2019-02-13 | 30-day Notice |
S337 | 2018-12-26 | Real-time Process |
S336 | 2018-12-18 | Real-time Process |
S335 | 2018-12-11 | 30-day Notice |
S334 | 2018-12-11 | 30-day Notice |
S333 | ||
S332 | 2018-11-21 | Real-time Process |
S331 | 2018-11-13 | 30-day Notice |
S330 | 2018-11-06 | 30-day Notice |
S329 | 2018-10-30 | 30-day Notice |
S328 | 2018-10-19 | 30-day Notice |
S327 | 2018-10-10 | 30-day Notice |
S326 | 2018-10-01 | 30-day Notice |
S325 | 2018-09-14 | 30-day Notice |
S324 | 2018-09-04 | 135 Review Track For 30-day Notice |
S323 | 2018-08-28 | 30-day Notice |
S322 | ||
S321 | 2018-08-02 | 30-day Notice |
S320 | 2018-07-17 | 30-day Notice |
S319 | 2018-06-18 | 30-day Notice |
S318 | 2018-05-24 | Normal 180 Day Track No User Fee |
S317 | 2018-05-18 | 30-day Notice |
S316 | 2018-05-16 | 30-day Notice |
S315 | 2018-05-07 | 30-day Notice |
S314 | 2018-05-02 | 30-day Notice |
S313 | 2018-04-26 | 30-day Notice |
S312 | 2018-04-16 | 30-day Notice |
S311 | 2018-03-22 | 30-day Notice |
S310 | 2018-03-12 | 30-day Notice |
S309 | 2018-01-05 | 135 Review Track For 30-day Notice |
S308 | 2017-12-18 | 30-day Notice |
S307 | 2017-12-15 | 30-day Notice |
S306 | 2017-11-20 | 30-day Notice |
S305 | 2017-11-20 | 30-day Notice |
S304 | 2017-11-16 | Normal 180 Day Track |
S303 | ||
S302 | 2017-11-13 | 30-day Notice |
S301 | 2017-11-06 | 30-day Notice |
S300 | 2017-10-20 | 30-day Notice |
S299 | 2017-09-27 | 30-day Notice |
S298 | 2017-09-20 | 30-day Notice |
S297 | 2017-09-20 | Special (immediate Track) |
S296 | 2017-09-13 | 30-day Notice |
S295 | 2017-09-08 | 30-day Notice |
S294 | 2017-09-05 | Normal 180 Day Track No User Fee |
S293 | 2017-09-01 | Normal 180 Day Track No User Fee |
S292 | 2017-08-22 | 135 Review Track For 30-day Notice |
S291 | 2017-08-03 | 135 Review Track For 30-day Notice |
S290 | 2017-07-28 | 30-day Notice |
S289 | 2017-07-27 | 30-day Notice |
S288 | 2017-07-27 | 30-day Notice |
S287 | 2017-07-17 | 30-day Notice |
S286 | 2017-07-17 | Real-time Process |
S285 | 2017-07-17 | 30-day Notice |
S284 | 2017-06-07 | Real-time Process |
S283 | 2017-05-23 | 30-day Notice |
S282 | 2017-05-18 | 30-day Notice |
S281 | 2017-05-03 | 30-day Notice |
S280 | 2017-04-28 | 30-day Notice |
S279 | 2017-04-26 | 30-day Notice |
S278 | 2017-04-25 | 30-day Notice |
S277 | 2017-04-14 | 30-day Notice |
S276 | 2017-04-03 | 30-day Notice |
S275 | 2017-04-03 | 30-day Notice |
S274 | 2017-03-29 | 30-day Notice |
S273 | 2017-03-10 | Special (immediate Track) |
S272 | 2017-03-09 | 30-day Notice |
S271 | 2017-03-03 | 30-day Notice |
S270 | 2017-01-13 | 30-day Notice |
S269 | 2017-01-11 | 30-day Notice |
S268 | 2017-01-09 | 30-day Notice |
S267 | 2016-11-23 | 30-day Notice |
S266 | 2016-11-21 | 30-day Notice |
S265 | 2016-11-14 | 30-day Notice |
S264 | 2016-11-03 | 30-day Notice |
S263 | 2016-08-15 | 30-day Notice |
S262 | 2016-08-15 | 30-day Notice |
S261 | 2016-08-12 | 30-day Notice |
S260 | 2016-08-01 | 30-day Notice |
S259 | 2016-07-29 | 30-day Notice |
S258 | 2016-07-25 | 30-day Notice |
S257 | 2016-06-30 | 30-day Notice |
S256 | 2016-06-27 | 30-day Notice |
S255 | 2016-06-27 | 30-day Notice |
S254 | 2016-06-09 | 30-day Notice |
S253 | 2016-06-07 | 30-day Notice |
S252 | 2016-06-06 | 30-day Notice |
S251 | 2016-05-31 | 30-day Notice |
S250 | 2016-04-27 | 30-day Notice |
S249 | 2016-04-05 | 30-day Notice |
S248 | 2016-03-04 | 30-day Notice |
S247 | 2016-02-11 | 30-day Notice |
S246 | 2016-02-08 | Normal 180 Day Track |
S245 | 2015-12-28 | 30-day Notice |
S244 | 2015-12-23 | 30-day Notice |
S243 | 2015-12-14 | Real-time Process |
S242 | 2015-11-23 | 30-day Notice |
S241 | 2015-10-29 | 30-day Notice |
S240 | 2015-10-13 | 30-day Notice |
S239 | 2015-09-30 | 30-day Notice |
S238 | 2015-09-14 | 30-day Notice |
S237 | 2015-08-31 | 135 Review Track For 30-day Notice |
S236 | 2015-07-23 | 30-day Notice |
S235 | 2015-07-14 | 30-day Notice |
S234 | 2015-06-17 | 30-day Notice |
S233 | 2015-06-16 | 30-day Notice |
S232 | 2015-06-08 | 30-day Notice |
S231 | 2015-06-01 | 30-day Notice |
S230 | 2015-05-28 | Special (immediate Track) |
S229 | 2015-05-21 | Normal 180 Day Track |
S228 | 2015-05-15 | 30-day Notice |
S227 | 2015-05-11 | 30-day Notice |
S226 | 2015-04-30 | 30-day Notice |
S225 | 2015-04-28 | 30-day Notice |
S224 | 2015-03-19 | 30-day Notice |
S223 | 2015-03-09 | 30-day Notice |
S222 | 2015-03-06 | 30-day Notice |
S221 | 2015-02-27 | 30-day Notice |
S220 | 2015-02-27 | Real-time Process |
S219 | 2015-02-24 | Panel Track |
S218 | 2015-02-18 | 30-day Notice |
S217 | 2015-02-04 | 30-day Notice |
S216 | 2015-01-23 | 30-day Notice |
S215 | 2015-01-12 | 30-day Notice |
S214 | 2015-01-12 | 30-day Notice |
S213 | 2015-01-09 | 30-day Notice |
S212 | 2014-11-24 | 30-day Notice |
S211 | 2014-11-17 | Normal 180 Day Track |
S210 | 2014-10-23 | 30-day Notice |
S209 | 2014-09-18 | 30-day Notice |
S208 | 2014-09-16 | 30-day Notice |
S207 | 2014-09-16 | 30-day Notice |
S206 | 2014-09-04 | 30-day Notice |
S205 | 2014-08-25 | 30-day Notice |
S204 | 2014-08-20 | 30-day Notice |
S203 | 2014-08-11 | Real-time Process |
S202 | 2014-08-01 | 30-day Notice |
S201 | 2014-08-01 | Special (immediate Track) |
S200 | 2014-07-30 | 30-day Notice |
S199 | 2014-07-03 | 30-day Notice |
S198 | 2014-07-02 | 30-day Notice |
S197 | 2014-06-19 | Normal 180 Day Track |
S196 | 2014-06-04 | 30-day Notice |
S195 | 2014-05-30 | 30-day Notice |
S194 | 2014-04-25 | 30-day Notice |
S193 | 2014-03-31 | Special (immediate Track) |
S192 | 2014-03-28 | 30-day Notice |
S191 | 2014-03-13 | 30-day Notice |
S190 | 2014-03-05 | 30-day Notice |
S189 | 2014-02-18 | 30-day Notice |
S188 | 2014-02-04 | 135 Review Track For 30-day Notice |
S187 | 2013-12-23 | 30-day Notice |
S186 | 2013-11-13 | 30-day Notice |
S185 | 2013-10-25 | 30-day Notice |
S184 | 2013-09-30 | 30-day Notice |
S183 | 2013-09-24 | 30-day Notice |
S182 | 2013-09-23 | 30-day Notice |
S181 | 2013-09-23 | 30-day Notice |
S180 | 2013-09-13 | 30-day Notice |
S179 | 2013-09-09 | 30-day Notice |
S178 | 2013-07-29 | 30-day Notice |
S177 | 2013-07-29 | 30-day Notice |
S176 | 2013-07-17 | 30-day Notice |
S175 | 2013-07-12 | 30-day Notice |
S174 | 2013-07-03 | 30-day Notice |
S173 | 2013-06-06 | Real-time Process |
S172 | 2013-05-31 | 135 Review Track For 30-day Notice |
S171 | 2013-04-29 | 30-day Notice |
S170 | 2013-03-21 | 135 Review Track For 30-day Notice |
S169 | 2013-03-18 | Normal 180 Day Track No User Fee |
S168 | 2013-03-18 | 30-day Notice |
S167 | 2013-02-11 | Real-time Process |
S166 | 2013-02-08 | 135 Review Track For 30-day Notice |
S165 | 2013-02-07 | Real-time Process |
S164 | 2013-02-01 | 30-day Notice |
S163 | ||
S162 | 2013-01-22 | 30-day Notice |
S161 | 2012-12-11 | 30-day Notice |
S160 | 2012-10-05 | Real-time Process |
S159 | 2012-10-04 | 30-day Notice |
S158 | 2012-09-25 | 30-day Notice |
S157 | 2012-09-10 | 30-day Notice |
S156 | 2012-08-31 | Normal 180 Day Track No User Fee |
S155 | 2012-08-20 | 30-day Notice |
S154 | 2012-08-14 | 30-day Notice |
S153 | 2012-07-25 | 30-day Notice |
S152 | 2012-07-23 | 135 Review Track For 30-day Notice |
S151 | 2012-07-13 | 30-day Notice |
S150 | 2012-07-02 | 30-day Notice |
S149 | 2012-06-22 | Real-time Process |
S148 | 2012-05-17 | 30-day Notice |
S147 | 2012-05-09 | 30-day Notice |
S146 | 2012-05-09 | 30-day Notice |
S145 | 2012-05-07 | 30-day Notice |
S144 | 2012-04-30 | 30-day Notice |
S143 | 2012-04-10 | 30-day Notice |
S142 | 2012-04-04 | Special (immediate Track) |
S141 | 2012-04-02 | 30-day Notice |
S140 | ||
S139 | 2012-03-26 | 30-day Notice |
S138 | 2012-03-22 | 30-day Notice |
S137 | 2012-03-16 | 30-day Notice |
S136 | 2011-12-21 | 30-day Notice |
S135 | 2011-12-16 | 30-day Notice |
S134 | 2011-12-12 | Real-time Process |
S133 | 2011-12-08 | 30-day Notice |
S132 | 2011-11-04 | 30-day Notice |
S131 | 2011-10-11 | 30-day Notice |
S130 | 2011-10-11 | 30-day Notice |
S129 | 2011-10-05 | 30-day Notice |
S128 | 2011-10-04 | 30-day Notice |
S127 | 2011-09-22 | 30-day Notice |
S126 | ||
S125 | 2011-07-29 | Special (immediate Track) |
S124 | 2011-07-22 | 30-day Notice |
S123 | 2011-07-19 | 30-day Notice |
S122 | 2011-07-06 | 30-day Notice |
S121 | 2011-06-29 | 30-day Notice |
S120 | 2011-06-10 | 30-day Notice |
S119 | 2011-06-06 | 30-day Notice |
S118 | 2011-05-23 | 30-day Notice |
S117 | 2011-05-20 | 30-day Notice |
S116 | 2011-05-18 | 30-day Notice |
S115 | 2011-04-18 | 135 Review Track For 30-day Notice |
S114 | 2011-04-04 | 30-day Notice |
S113 | 2011-03-30 | 30-day Notice |
S112 | 2011-03-16 | 135 Review Track For 30-day Notice |
S111 | 2011-02-16 | 30-day Notice |
S110 | 2011-02-07 | 30-day Notice |
S109 | 2011-02-07 | 30-day Notice |
S108 | 2011-02-03 | Real-time Process |
S107 | 2010-12-27 | 30-day Notice |
S106 | 2010-12-21 | Special (immediate Track) |
S105 | 2010-12-08 | 30-day Notice |
S104 | 2010-12-07 | 30-day Notice |
S103 | 2010-11-26 | 30-day Notice |
S102 | 2010-11-24 | 30-day Notice |
S101 | 2010-11-22 | 30-day Notice |
S100 | 2010-10-25 | 30-day Notice |
S099 | 2010-10-12 | 30-day Notice |
S098 | ||
S097 | 2010-09-14 | 30-day Notice |
S096 | 2010-08-31 | 30-day Notice |
S095 | 2010-08-17 | 30-day Notice |
S094 | 2010-08-11 | 30-day Notice |
S093 | 2010-08-11 | 30-day Notice |
S092 | 2010-08-02 | Normal 180 Day Track |
S091 | 2010-07-30 | 30-day Notice |
S090 | 2010-08-02 | Normal 180 Day Track |
S089 | 2010-07-08 | 135 Review Track For 30-day Notice |
S088 | 2010-06-30 | 30-day Notice |
S087 | 2010-06-28 | 30-day Notice |
S086 | ||
S085 | 2010-06-03 | 30-day Notice |
S084 | 2010-06-01 | 30-day Notice |
S083 | 2010-05-03 | Real-time Process |
S082 | 2010-04-20 | 30-day Notice |
S081 | 2010-04-15 | 30-day Notice |
S080 | 2010-04-01 | Special (immediate Track) |
S079 | 2010-04-02 | 30-day Notice |
S078 | 2010-02-01 | 30-day Notice |
S077 | 2010-01-27 | 30-day Notice |
S076 | 2009-12-23 | 30-day Notice |
S075 | 2010-01-07 | Real-time Process |
S074 | 2009-12-14 | 30-day Notice |
S073 | 2009-12-03 | Normal 180 Day Track |
S072 | 2009-11-18 | 30-day Notice |
S071 | 2009-08-28 | Real-time Process |
S070 | 2009-08-24 | Normal 180 Day Track No User Fee |
S069 | 2009-08-20 | 30-day Notice |
S068 | ||
S067 | 2009-04-15 | Real-time Process |
S066 | 2009-04-14 | 30-day Notice |
S065 | 2009-04-13 | Special (immediate Track) |
S064 | 2009-02-24 | 30-day Notice |
S063 | 2009-02-12 | 30-day Notice |
S062 | 2009-02-06 | 30-day Notice |
S061 | 2009-01-02 | 30-day Notice |
S060 | 2008-12-19 | Normal 180 Day Track No User Fee |
S059 | 2008-12-17 | 30-day Notice |
S058 | 2008-12-15 | 30-day Notice |
S057 | 2008-12-11 | Normal 180 Day Track No User Fee |
S056 | ||
S055 | 2008-07-24 | 135 Review Track For 30-day Notice |
S054 | 2008-06-30 | 135 Review Track For 30-day Notice |
S053 | ||
S052 | 2008-06-06 | Normal 180 Day Track |
S051 | 2008-04-24 | Normal 180 Day Track |
S050 | 2008-04-23 | 30-day Notice |
S049 | 2008-04-14 | Normal 180 Day Track No User Fee |
S048 | 2008-03-26 | 30-day Notice |
S047 | 2008-03-10 | 135 Review Track For 30-day Notice |
S046 | 2008-02-25 | 30-day Notice |
S045 | 2007-11-23 | 30-day Notice |
S044 | 2007-10-09 | 30-day Notice |
S043 | 2007-09-17 | 135 Review Track For 30-day Notice |
S042 | 2007-09-17 | Special (immediate Track) |
S041 | 2007-08-31 | Real-time Process |
S040 | 2006-06-05 | Real-time Process |
S039 | 2006-05-15 | Real-time Process |
S038 | ||
S037 | 2006-02-06 | Special (immediate Track) |
S036 | 2005-12-28 | Real-time Process |
S035 | 2005-11-04 | Special (immediate Track) |
S034 | 2005-11-02 | 30-day Notice |
S033 | 2005-10-06 | 135 Review Track For 30-day Notice |
S032 | 2005-03-23 | 30-day Notice |
S031 | ||
S030 | 2004-07-20 | Normal 180 Day Track No User Fee |
S029 | 2004-06-01 | Real-time Process |
S028 | 2003-08-25 | Normal 180 Day Track No User Fee |
S027 | 2002-08-27 | Normal 180 Day Track |
S026 | 2002-07-15 | Real-time Process |
S025 | 2002-05-10 | Normal 180 Day Track |
S024 | 2002-02-25 | Real-time Process |
S023 | 2001-12-07 | 30-day Notice |
S022 | 2001-11-13 | Special (immediate Track) |
S021 | 2001-09-19 | Special (immediate Track) |
S020 | 2001-07-10 | Special (immediate Track) |
S019 | 2001-07-03 | Normal 180 Day Track |
S018 | 2001-06-15 | Special (immediate Track) |
S017 | 2001-05-23 | Special (immediate Track) |
S016 | 2001-04-16 | Normal 180 Day Track |
S015 | 2000-11-16 | 30-day Notice |
S014 | 2000-10-26 | Normal 180 Day Track |
S013 | ||
S012 | 2000-04-18 | Special (immediate Track) |
S011 | ||
S010 | 2000-02-22 | Normal 180 Day Track |
S009 | 2000-01-18 | Real-time Process |
S008 | 1999-10-28 | Normal 180 Day Track |
S007 | 1999-09-30 | Panel Track |
S006 | 1999-02-24 | Special (immediate Track) |
S005 | 1999-01-12 | Real-time Process |
S004 | 1998-12-29 | Special (immediate Track) |
S003 | 1998-10-08 | Real-time Process |
S002 | 1998-03-05 | Normal 180 Day Track |
S001 | 1997-11-19 | Normal 180 Day Track |