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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 BrianSense
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 NumberS316
Date Received03/18/2022
Decision Date06/15/2022
Product Code
MRU[ Registered Establishments with MRU ]
Advisory Committee Neurology
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Changes to the medtronic model a610 dbs clinician programmer application version 3. 0. The changes consist of a fix to a software defect subject to field corrective action fa1188 reported to fda on september 23, 2021, as well as fixes to other minor defects in the a610 application.
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