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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 NumberS207
Date Received11/16/2017
Decision Date05/26/2018
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 
Medtronic’s new model a610 activa clinician programmer application and model 8880t2 communicator intended for programming dbs systems. The supplement also requested approval for a field-implementable update to the model 37612 activa rc implantable neurostimulator to extend the service life from 9 years to 15 years.
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