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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 NumberS315
Date Received01/29/2024
Decision Date04/09/2024
Product Code
OLM[ Registered Establishments with OLM ]
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 a minor design change to a radio frequency (rf) pin diode of the telemetry-m (tel-m) communication circuit and consequent minor change to the printed circuit board (pcb) used on the intellis 8880t2 (clinician telemetry module, ctm2), 97745 / 97745fa (programmer patient therapy manager, ptm3), and 97745nt (programmer patient therapy manager, ptm3 no bluetooth).
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