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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePercept Deep Brain Stimulation Therapy Systems
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP960009
Supplement NumberS394
Date Received12/18/2020
Decision Date01/15/2021
Product Code MHY 
Advisory Committee Neurology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for use of a screening tool to screen/filter out a list of invalid hybrid serial numbers from the next available 1,048,564 serial numbers. The resulting invalid hybrid serial numbers are to be programmed into the FACTORYworks table to prevent them from being used for future hybrid manufacturing builds.
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