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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 NameACTIVA 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 NumberS162
Date Received06/27/2016
Decision Date07/27/2016
Product Code
MRU[ Registered Establishments with MRU ]
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Update to the welding process parameters, welding electrode tip geometry, and accompanying documentation used in the manufacture of your medium rate battery assemblies for your restore, itrel, and synergy spinal cord stimulation (scs) systems; activa deep brain stimulation (dbs) therapy system; activa dystonia therapy system; reclaim dbs therapy for ocd system; interstim therapy system; enterra therapy system; and syncromed infusion system.
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