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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.
 
Trade NameMEDTRONIC MODEL 7482 DBS EXTENSION
Classification Namestimulator, electrical, implanted, for parkinsonian tremor
Generic Nameimplantable electrical thalmic stimulation system - deep brain stimulation
ApplicantMEDTRONIC VASCULAR
PMA NumberP960009
Supplement NumberS026
Date Received07/15/2002
Decision Date10/31/2002
Product Code
MHY[ Registered Establishments with MHY ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following changes to the approved model 7482 dbs extension; combine low profile design and technology with a low impedance conductor, change the coating used on the outside diameter to siloxane, add a new torque wrench to the extension package, and add a new model 3550-25 boots accessory kit.
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