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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 NumberS317
Date Received02/28/2024
Decision Date07/01/2024
Product Code
OLM[ Registered Establishments with OLM ]
Advisory Committee Neurology
Supplement Typenormal 75 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Which requested approval for the following changes for each supplement:for p960009/s474 for:• the removal of the contraindication: “implantation of a deep brain stimulation system is contraindicated for patients for whom test stimulation is unsuccessful and the addition of a precaution that specifies two conditions under which full system implantation can occur (i. E. , successful test stimulation, or confirmation of lead implantation to the targeted site via imaging. )• an update to mri labeling to allow additional active scan time for scans below specified b1+rms limits. For h020007/s364 and h050003/s317 for:• an update to mri labeling to allow additional active scan time for scans below specified b1+rms limits.
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