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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 NumberS289
Date Received08/29/2022
Decision Date01/08/2024
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 the following: for p960009/s438, approval for: • model b35300 percept rc implantable neurostimulator (ins)• model rs6230 recharger kit (including the wr9230 recharger)• model a610 clinician programmer application (ppa) software (version 4. 0) • model a620 patient programmer application (cpa) (version 3. 0) • a90300 recharger application software (ras) (version 2. 0) • labeling changes in physician and patient labeling for existing products, to be consistent with the proposed labeling for the new percept rc system. For h020007/s329, approval for: • model b35300 percept rc implantable neurostimulator (ins)• model rs6230 recharger kit (including the wr9230 recharger)• model a610 clinician programmer application (ppa) software (version 4. 0) • model a620 patient programmer application (cpa) (version 3. 0) • a90300 recharger application software (ras) (version 2. 0) • dystonia kits (models 33th60, 33th76, and 33th69) • labeling changes in physician and patient labeling for existing products, to be consistent with the proposed labeling for the new percept rc system. For h050003/s289, approval for:• model a610 clinician programmer application (ppa) software (version 4. 0) for p840001/s527, approval for: • labeling changes in physician and patient labeling for existing products, to be consistent with the proposed labeling for the new percept rc system.
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