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Trade Name | Reclaim DBS Therapy for Obsessive Compulsive Disorder (OCD) System |
Classification Name | deep brain stimulator for obsessive compulsive disorder (ocd) |
Generic Name | deep brain stimulator for obsessive compulsive disorder (ocd) |
Applicant |
MEDTRONIC INC.,NEUROLOGICAL DIVISION |
7000 central avenue northeast |
minneapolis, MN 55432 |
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HDE Number | H050003 |
Supplement Number | S176 |
Date Received | 11/16/2017 |
Decision Date | 05/26/2018 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Medtronic’s new model a610 activa clinician programmer application and model 8880t2 communicator intended for programming dbs systems. The supplement also requested approval for a field-implementable update to the model 37612 activa rc implantable neurostimulator to extend the service life from 9 years to 15 years. |