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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, Percept and SenSight Deep Brain Stimulation Therapy System
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 NumberS372
Date Received06/20/2024
Decision Date02/20/2025
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 
The following:• model a610 clinician programmer application (cpa) version 5. 0• labeling changes in clinician and patient labeling for existing products, to be consistent with the proposed labeling for the percept system with model a610 cpa version 5. 0.
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