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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
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantMedtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP960009
Supplement NumberS514
Date Received07/21/2025
Decision Date12/17/2025
Product Code MHY 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for using real-world evidence (RWE) from the Medtronic Registry for Epilepsy (MORE registry) as an alternative approach for the Epilepsy Post- Approval Study (EPAS study, P960009/S433) to meet the conditions of approval outlined in the FDA approval order for P960009/S219
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