This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the medtronic(r) activa(tm) tremor control system which includes the model 3387 dbs(tm) lead, model 7495 extension, model 7424 implantable pulse generator (ipg), model 7458 memory module, model 7432 console programmer, bur hole ring and cap, model 7452 magnet, model 3625 test stimulator (screener) and model 3353/3354 lead frame kits and accessories. This devic is indicated for unilateral thalamic stimulation for the suppression of tremor in the upper extremity in patients who are diagnosed with essential tremor or parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability.
Device | MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM |
Classification Name | Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Generic Name | Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Applicant | MEDTRONIC Inc. |
Date Received | 1996-05-01 |
Decision Date | 1997-07-31 |
Notice Date | 1998-11-12 |
PMA | P960009 |
Supplement | S |
Product Code | MHY |
Docket Number | 98M-0905 |
Advisory Committee | Neurology |
Expedited Review | Yes |
Combination Product | No |
Applicant Address | MEDTRONIC Inc. 7000 Central Avenue Ne minneapolis, MN 55432-3576 |
Post-Approval Study: | Show Report Schedule and Study Progress |
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 |