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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.
 
DeviceActivia Deep Brain Stimulation Therapy System
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP960009
Supplement NumberS365
Date Received12/02/2019
Decision Date06/25/2020
Product Code MHY 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the new WR9200 Wireless Recharger Subsystem and associated labeling. The new WR9200 Wireless Recharger Subsystem is intended to recharge the Activa RC implantable neurostimulator (INS) for Deep Brain Stimulation Therapy and the following Restore INSs for Spinal Cord Stimulation Therapy: RestoreUltra; RestoreUltra SureScan MRI; RestoreSensor; and RestoreSensor SureScan MRI.
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