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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
Classification Nameimplanted subcortical electrical stimulator (motor disorders)
Generic Nameimplanted subcortical electrical stimulator (motor disorders)
Applicant
Medtronic Neuromodulation
7000 central ave., ne, rcw225
minneapolis, MN 55432
HDE NumberH020007
Supplement NumberS021
Date Received07/24/2008
Decision Date10/17/2008
Product Code
MRU[ Registered Establishments with MRU ]
Advisory Committee Neurology
Supplement Typenormal 75 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the implementation of the sterilization automated release or stair system to the sterilization operation at the medtronic neuromodulation sullivan lakemanufacturing facility.
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