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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 NameDBS ACCESSORIES,DBS EXTENSIONS,DBS LEADS,DBS NEUROSTIMULATORS IMPLANTABLE,DBS NEUROSTIMULATORS SOLETRA FAMILY
Classification Namestimulator, electrical, implanted, for parkinsonian tremor
Applicant MEDTRONIC INC.
PMA NumberP960009
Supplement NumberS161
Date Received12/11/2012
Decision Date01/08/2013
Product Code
MHY[ Registered Establishments with MHY ]
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Use an updated version of the software already in use at various facilities to ensure compliance to training requirements, proper documentation associated with disposition of product, and proper function of the software by correcting minor issues present in the current software version.
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