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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.
 
DeviceMEDTRONIC ACTIVA TREMOR CONTROL SYSTEM
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP960009
Supplement NumberS461
Date Received08/31/2023
Decision Date11/29/2023
Product Code MHY 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
approval for new firmware version 2.1.021 for the Medtronic Wireless Recharger Model WR9200, new LED supplier for the WR9200 indicator, labeling update for the Unique Device Identification and backplate regulatory symbols, and manufacturing and development environment changes for the Secure Digital Card, software, and firmware
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