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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.
 
DeviceActiva™ Deep Brain Stimulation Therapy System, Percept PC/RC BrainSense™
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantMedtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP960009
Supplement NumberS524
Date Received09/29/2025
Decision Date12/08/2025
Product Code MHY 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for updates to the Model A610 Deep Brain Stimulation Clinician Programmer Application version 5.0, which updates background loading of event logs, user interface revisions, and bug fix revisions.
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