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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)
7000 central avenue ne
rcw 225
minneapolis, MN 55432
HDE NumberH020007
Supplement NumberS299
Date Received08/03/2021
Decision Date09/01/2021
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 
Approval for 1) equipment updates in the cea 2-3 silicone molding area (e. G. , six additional ovens), updated option for use of temperature recorder (vaisala monitoring system model vl-1700-54t), updated oven mode for the new ovens to use manual mode, removal of monitor lot for all ovens, removal of setup lot of new ovens, addition of a new and smaller basket for oven use, and addition of a new toolmaker scope (nikon mm-40), 2) an update to the applicable work instructions (wi), and 3) the oven operation of allowing the new ovens to be opened during the middle of a run to add or remove lots from the oven and factoryworks (fw) updates to support the changes.