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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 avenue ne
rcw 225
minneapolis, MN 55432
HDE NumberH020007
Supplement NumberS325
Date Received07/11/2022
Decision Date08/10/2022
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 
To add tse/ametek as an alternate supplier for the sensight lead test cable kit and sensight extension test cable kit.
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