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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 avenue ne
rcw 225
minneapolis, MN 55432
HDE NumberH020007
Supplement NumberS124
Date Received11/17/2014
Decision Date11/04/2015
Product Code
MRU[ Registered Establishments with MRU ]
Advisory Committee Neurology
Supplement Typenormal 75 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for 1) expanded mri conditions for medtronic dbs systems, 2) updates to the model 37651 patient recharger system, 3) clarifications to the guidelines for conducting ct scans on dbs patients, 4) addition of symbols to sterile and shelf-box package labels for specified models, and; 5) updates to package configurations for specified models.
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