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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 | S180 |
Date Received | 01/05/2018 |
Decision Date | 06/02/2018 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | normal 75 day track |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for adding an alternate supplier to manufacture the coil components used in the implanted leads of the deep brain stimulator (dbs), spinal cord stimulation (scs), and sacral nerve stimulation (sns) devices. |