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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 | S131 |
Date Received | 06/27/2016 |
Decision Date | 07/27/2016 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Update to the welding process parameters, welding electrode tip geometry, and accompanying documentation used in the manufacture of your medium rate battery assemblies for your restore, itrel, and synergy spinal cord stimulation (scs) systems; activa deep brain stimulation (dbs) therapy system; activa dystonia therapy system; reclaim dbs therapy for ocd system; interstim therapy system; enterra therapy system; and syncromed infusion system. |