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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 and Percept Deep Brain Stimulation Therapy System
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantMedtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP960009
Supplement NumberS486
Date Received09/30/2024
Decision Date12/23/2024
Product Code MHY 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for changes to the sterile barrier packaging and shelf box changes, instructions for use (IFU) and package labels, and reduction in labeled shelf life from 48 months to 24 months for the Medtronic Pocket Adaptor Kits (Model 64001 1x4 and Model 64002 2x4) for Deep Brain Stimulation.
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