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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, Percept PC BrainSense™
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 NumberS411
Date Received10/16/2025
Decision Date11/26/2025
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 
A manufacturing site change to add medtronic puerto rico operations company, villalba facility (mvc) as an alternate sterilization site for neuromodulation/pelvic health (nmph) implantable neurostimulators (ins), drug delivery infusion pumps (synchromed), catheters and accessories.
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