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Trade Name | Reclaim DBS Therapy for Obsessive Compulsive Disorder |
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 | S159 |
Date Received | 07/17/2017 |
Decision Date | 09/26/2017 |
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 Approval for minor specification and material changes to the antenna wire and solder composition used in the model 37092 external antenna, in addition to minor manufacturing changes and minor design changes to the exterior mold. |