| 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. |
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| Trade Name | MEDTRONIC ACTIVA PARKINSON'S CONTROL SYSTEM |
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| Classification Name | stimulator, electrical, implanted, for parkinsonian symptoms |
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| Generic Name | implantable electrical thalmic stimulation system - deep brain stimulation |
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| Applicant | MEDTRONIC VASCULAR |
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| PMA Number | P960009 |
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| Supplement Number | S007 |
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| Date Received | 09/30/1999 |
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| Decision Date | 01/14/2002 |
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| Product Code | |
| Docket Number | 02M-0217 |
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| Notice Date | 05/13/2002 |
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| Advisory Committee |
Neurology |
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| Supplement Type | panel track |
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| Supplement Reason | labeling change - indications |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
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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
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