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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 NameINSS FOR OBSESSIVE-COMPULSIVE DISORDER/LEAD KITS
Classification Namestimulator, brain, implanted, for behavior modification
Generic Namestimulator, brain, implanted, for behavior modification
Applicant
Medtronic Inc.,Neurological Division.
7000 central ave., northeast
minneapolis, MN 55432
HDE NumberH050003
Supplement NumberS021
Date Received06/27/2011
Decision Date10/06/2011
Product Code
MFR[ Registered Establishments with MFR ]
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 
Approval of the activa sc and activa pc for use with the reclaim dbs therapy for ocd and the implementation of a revised labeling architecture for reclaim dbs therapy for ocd.
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