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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 FOaReclaim™ DBS Therapy for Obsessive Compulsive Disorder (OCD) System (DBS Imp
Classification Namedeep brain stimulator for obsessive compulsive disorder (ocd)
Generic Namedeep brain stimulator for obsessive compulsive disorder (ocd)
Applicant
Medtronic Inc.,Neurological Division.
7000 central ave., northeast
minneapolis, MN 55432
HDE NumberH050003
Supplement NumberS366
Date Received03/09/2026
Decision Date04/03/2026
Product Code
OLM[ Registered Establishments with OLM ]
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 an update to the equipment used to perform final functional testing on medtronic neuromodulation and pelvic health implantable devices.
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