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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namestimulator, electrical, implanted, for parkinsonian tremor
Generic Nameimplantable electrical thalmic stimulation system - deep brain stimulation
PMA NumberP960009
Date Received05/01/1996
Decision Date07/31/1997
Product Code
MHY[ Registered Establishments with 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
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