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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 NameReclaim™ DBS Therapy for Obsessive Compulsive Disorder (OCD) System (B35200)
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 NumberS368
Date Received05/08/2026
Decision Date06/05/2026
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 
For expansion of incoming electrolyte salt acceptance limits. Specifically, to expand liasf6 electrolyte salt moisture content acceptance limit from: = 100 parts per million (ppm) to: = 200 ppm and expand liasf6 electrolyte salt insoluble acceptance limit from: = 20 ppm to: = 200 ppm.
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