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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 NameDEEP BRAIN STIMULATION THERAPY
Classification Namestimulator, electrical, implanted, for parkinsonian tremor
Generic Namestimulator, electrical, implanted, for parkinsonian tremor
ApplicantMEDTRONIC Inc.
PMA NumberP960009
Supplement NumberS075
Date Received01/07/2010
Decision Date03/04/2010
Product Code
MHY
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the reformulation of the hotmelt adhesive used for the medtronic neuromodulation sterile barrier blister packages.
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