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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name external cerebrospinal fluid (csf) diversion
De Novo Number DEN120017
Device Name Medtronic DUET External Drainage and Monitoring System
Requester
MEDTRONIC NEUROSURGERY
125 cremona dr.
goleta,  CA  93117
Contact donovan may
Regulation Number882.5560
Classification Product Code
PCB  
Date Received12/21/2012
Decision Date 08/22/2014
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Post-NSE
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