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Trade Name | INSS FOR OBSESSIVE-COMPULSIVE DISORDER/LEAD KITS |
Classification Name | stimulator, brain, implanted, for behavior modification |
Generic Name | stimulator, brain, implanted, for behavior modification |
Applicant |
MEDTRONIC INC.,NEUROLOGICAL DIVISION |
7000 central avenue northeast |
minneapolis, MN 55432 |
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HDE Number | H050003 |
Supplement Number | S021 |
Date Received | 06/27/2011 |
Decision Date | 10/06/2011 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | normal 75 day track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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. |