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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device.
 
Trade NamePercept and Activa Dystonia Therapy System
Classification Nameimplanted subcortical electrical stimulator (motor disorders)
Generic Nameimplanted subcortical electrical stimulator (motor disorders)
Applicant
MEDTRONIC NEUROMODULATION
7000 central avenue ne
rcw 225
minneapolis, MN 55432
HDE NumberH020007
Supplement NumberS279
Date Received09/04/2020
Decision Date06/09/2021
Product Code
MRU[ Registered Establishments with MRU ]
Advisory Committee Neurology
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for 1) the pain pc system for spinal cord stimulation (scs) which includes implantable neurostimulation systems vanta™ with adaptivestim™ and sequentia™ lt; and 2) modified labeling for the model b31060 connector plug to reflect its intended use with the pain pc system 3) labeling updates for previously approved devices to be consistent with pain pc system labeling.
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