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 changes being effected (cbe) for the p960009 deep brain stimulation therapy system for parkinson's disease. The changes being effected include changes to medtronic dbs therapy physician and patient labeling, to enhance and harmonize the information regarding the risks of depression, suicide ideation, and suicide across the device type, as requested in the fda labeling change request letter dated june 24, 2019.
Device | Deep Brain Stimulation Therapy System for Parkinson's Disease |
Classification Name | Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Generic Name | Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Applicant | MEDTRONIC Inc. |
Date Received | 2019-08-05 |
Decision Date | 2019-09-04 |
PMA | P960009 |
Supplement | S357 |
Product Code | MHY |
Advisory Committee | Neurology |
Supplement Type | Special (immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
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 |