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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:  S001 S002 S003 S004 S005 S006 S007 S008 
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S060 S061 S062 S063 S064 S065 S066 S067 S069 
S070 S071 S072 S073 S074 S075 S076 S077 S078 
S079 S080 S081 S082 S083 S084 S085 S087 S088 
S089 S090 S091 S092 S093 S094 S095 S096 S097 
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S108 S109 S110 S111 S112 S113 S114 S115 S116 
S117 S118 S119 S120 S121 S122 S123 S124 S125 
S127 S128 S129 S130 S131 S132 S133 S134 S135 
S136 S137 S138 S139 S141 S142 S143 S144 S145 
S146 S147 S148 S149 S150 S151 S152 S153 S154 
S155 S156 S157 S158 S159 S160 S161 S162 S164 
S165 S166 S167 S168 S169 S170 S171 S172 S173 
S174 S175 S176 S177 S178 S179 S180 S181 S182 
S183 S184 S185 S186 S187 S188 S189 S190 S191 
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S201 S202 S203 S204 S205 S206 S207 S208 S209 
S210 S211 S212 S213 S214 S215 S216 S217 S218 
S219 S220 S221 S222 S223 S224 S225 S226 S227 
S228 S229 S230 S231 S232 S233 S234 S235 S236 
S237 S238 S239 S240 S241 S242 S243 S244 S245 
S246 S247 S248 S249 S250 S251 S252 S253 S254 
S255 S256 S257 S258 S259 S260 S261 S262 S263 
S264 S265 S266 S267 S268 S269 S270 S271 S272 
S273 S274 S275 S276 S277 S278 S279 S280 S281 
S282 S283 S284 S285 S286 S287 S288 S289 S290 
S291 S292 S293 S294 S295 S296 S297 S298 S299 
S300 S301 S302 S303 S304 S305 S306 S307 S308 
S309 S310 S311 S312 S313 S314 S315 S316 S317 
S318 S319 S320 S321 S322 S323 S324 S325 S326 
S327 S328 S329 S330 S331 S332 S333 S334 S335 
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S373 S374 S375 
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