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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 NameMEDTRONIC ACTIVA DEEP BRAIN STIMULATION (DBS)SYSTEM
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 NumberS003
Date Received06/01/2004
Decision Date07/30/2004
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 incorporating a polyether urethane material change to the approved model 3307 activa®) dystonia therapy kit (with model 3387 lead and model7482 extension) and model 3309 activa® dystonia therapy kit (with model 3389 lead and model 7482 extension).
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