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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 ave., ne, rcw225
minneapolis, MN 55432
HDE NumberH020007
Supplement NumberS197
Date Received09/05/2017
Decision Date04/13/2018
Product Code
MRU[ Registered Establishments with MRU ]
Advisory Committee Neurology
Supplement Typenormal 75 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Requested approval for a manufacturing site located at road 31, km. 24, hm 4, ceiba norte industrial park, juncos, puerto rico 00777, for kitting activities including sterile packaging, sterilization, final pack & label, and final qa inspection.
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