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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 tremor
Generic Nameimplantable electrical thalmic stimulation system - deep brain stimulation
PMA NumberP960009
Supplement NumberS002
Date Received03/05/1998
Decision Date09/01/1998
Product Code
MHY[ Registered Establishments with MHY ]
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason pas protocal supplement ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of a protocol to assess the neurotoxicity and carcinogenicity of the medtronic model 3387 dbs lead. The work performed under this protocol is intended to fulfill one of the four conditions of approval of the pma.