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Trade Name | Reclaim DBS Therapy for Obessive 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 | S203 |
Date Received | 12/18/2018 |
Decision Date | 03/01/2019 |
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 Add a polyethylene terephthalate (pet) slip tube over proximal end of each cable conductor to prevent mechanical locking of the build epoxy to the ethylene tetrafluoroethylene (etfe) coated wire cables for dbs extension models 37085 and 37086. |