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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: 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.
 
DeviceMEDTRONIC ACTIVA TREMOR CONTROL SYSTEM
Generic Namestimulator, electrical, implanted, for parkinsonian tremor
Applicant
MEDTRONIC Inc.
7000 central avenue ne
minneapolis, MN 55432-3576
PMA NumberP960009
Date Received05/01/1996
Decision Date07/31/1997
Product Code MHY 
Docket Number 98M-0905
Notice Date 11/12/1998
Advisory Committee Neurology
Expedited Review Granted? Yes
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
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.
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S276 S267 S277 S261 S262 S263 S281 S259 
S282 S258 S257 S278 S265 S268 S251 S260 S264 
S275 S253 S255 S250 S266 S254 S270 S256 S249 
S247 S272 S271 S269 S283 S248 S252 S280 S279 
S274 S045 S034 S015 S076 S074 S100 S085 S084 
S044 S023 S099 S072 S066 S050 S097 S082 S081 
S048 S096 S079 S064 S063 S046 S032 S095 S062 
S094 S093 S091 S069 S061 S105 S078 S077 S059 
S104 S103 S102 S058 S101 S088 S087 S238 S175 
S150 S192 S174 S212 S186 S245 S199 S191 S244 
S224 S198 S190 S164 S159 S148 S136 S236 S223 
S185 S158 S147 S146 S145 S135 S133 S222 S221 
S210 S189 S162 S144 S242 S235 S184 S157 S218 
S196 S183 S182 S181 S143 S195 S180 S171 S141 
S132 S217 S209 S208 S207 S179 S161 S139 S241 
S234 S233 S206 S155 S154 S138 S137 S232 S205 
S131 S130 S129 S240 S231 S216 S204 S194 S153 
S239 S228 S227 S214 S215 S213 S187 S178 S151 
S226 S225 S202 S200 S177 S176 S168 S107 S124 
S123 S114 S113 S122 S121 S120 S128 S127 S119 
S111 S118 S110 S109 S117 S116 S273 S284 S246 
S035 S014 S075 S052 S033 S030 S024 S006 S040 
S029 S005 S004 S073 S067 S039 S065 S051 S003 
S049 S043 S042 S022 S012 S083 S041 S010 S080 
S021 S009 S047 S037 S020 S019 S018 S017 S008 
S007 S002 S092 S071 S070 S027 S016 S055 S036 
S028 S026 S090 S060 S089 S057 S054 S025 S001 
S237 S193 S149 S211 S167 S166 S165 S160 S173 
S243 S172 S134 S220 S197 S188 S156 S142 S230 
S229 S152 S203 S170 S201 S169 S106 S115 S125 
S112 S108 S392 S393 S390 S395 S388 S389 S377 
S346 S327 S335 S338 S331 S371 S373 S372 S368 
S360 S366 S352 S362 S326 S349 S343 S350 S356 
S329 S359 S364 S334 S387 S380 S386 S374 S384 
S375 S354 S381 S328 S342 S358 S370 S353 S367 
S379 S340 S330 S369 S323 S348 S345 S325 S316 
S298 S321 S307 S305 S295 S296 S302 S285 S308 
S310 S299 S300 S313 S301 S320 S287 S311 S289 
S288 S312 S314 S306 S319 S290 S317 S315 S394 
S322 S365 S336 S378 S361 S357 S332 S324 S351 
S363 S344 S382 S347 S383 S337 S339 S341 S333 
S286 S303 S304 S292 S309 S318 S293 S297 S294 
S291 S219 
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