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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 NumberS192
Date Received07/27/2017
Decision Date08/24/2017
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 
A transfer of receiving and incoming inspection activities for device components (i. E. , screw-conn set, crimp block 7495, and block- connector, set screw) used in the manufacture of medtronic neuromodulation therapy delivery products, from the medtronic rice creek facility to the medtronic puerto rico operations company (mproc)-villalba, mproc-juncos, and the fedex/3pl (third party logistics) facility in guaynabo, puerto rico.
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