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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namestimulator, electrical, implanted, for parkinsonian symptoms
Generic Namestimulator, electrical, implanted, for parkinsonian symptoms
7000 central avenue ne
minneapolis, MN 55432-3576
PMA NumberP960009
Supplement NumberS007
Date Received09/30/1999
Decision Date01/14/2002
Product Code
NHL[ Registered Establishments with NHL ]
Docket Number 02M-0217
Notice Date 05/13/2002
Advisory Committee Neurology
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the medtronic activa parkinson's control therapy which includes the model 3387 dbs lead, model 3389 dbs lead, model 7482 extension, model 7495 extension, model 7426 soletra neurostimulator, burr hole ring and cap, model 7432 physician programmer, model 7460 memorymod software cartridge, model 7452 patient magnet, model 3625 test stimulator, model 3353/3354 lead frame kit, and accessories. The device is indicated for bilateral stimulation of the internal globus pallidus (gpi) or the subthalamic nucleus (stn) as an adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive parkinson's disease that are not adequately controlled with medication.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress