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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 and Percept
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 NumberS375
Date Received09/30/2024
Decision Date12/23/2024
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 
Approval for changes to the sterile barrier packaging and shelf box changes, instructions for use (ifu) and package labels, and reduction in labeled shelf life from 48 months to 24 months for the medtronic pocket adaptor kits (model 64001 1x4 and model 64002 2x4) for deep brain stimulation.
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