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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 NumberS200
Date Received09/20/2017
Decision Date10/20/2017
Product Code
MRU[ Registered Establishments with MRU ]
Advisory Committee Neurology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Addition of new safety information (tunneling procedure unintended nerve tissue injury warning and adverse event, loss of coordination precaution, weight gain/loss adverse event) and safety enhancement clarifications (update guidance on avoiding damage to the neurostimulator (physician labeling), clarify text that accompanies the figure for accurate right and left hemisphere lead-extension connection when placing dual lead systems (physician labeling), remove incorrect length of the dbs lead placed under the scalp (patient labeling)).
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