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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
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 avenue northeast
minneapolis, MN 55432
HDE NumberH050003
Supplement NumberS257
Date Received12/18/2020
Decision Date01/15/2021
Product Code
OLM[ Registered Establishments with OLM ]
Advisory Committee Neurology
Supplement Typespecial (immediate track)
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
The center for devices and radiological health (cdrh) of the food and drug administration (fda) has completed its review of your premarket approval application (pma) supplement, which requested approval for use of a screening tool to screen/filter out a list of invalid hybrid serial numbers from the next available 1,048,564 serial numbers. The resulting invalid hybrid serial numbers are to be programmed into your factoryworks table to prevent them from being used for future hybrid manufacturing builds.
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