Medtronic DUET External Drainage And Monitoring System

External Cerebrospinal Fluid (csf) Diversion

MEDTRONIC NEUROSURGERY

The following data is part of a De Novo classification by Medtronic Neurosurgery with the FDA for Medtronic Duet External Drainage And Monitoring System.

Pre-market Notification Details

DeNovo IDDEN120017
Device Name:Medtronic DUET External Drainage And Monitoring System
ClassificationExternal Cerebrospinal Fluid (csf) Diversion
Applicant MEDTRONIC NEUROSURGERY 125 Cremona Dr. Goleta,  CA  93117
ContactDonovan May
Product CodePCB  
CFR Regulation Number882.5560 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardNeurology
Classification AdvisoryNeurology
TypePost-NSE
Date Received2012-12-21
Decision Date2014-08-22
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00763000396008 DEN120017 000
00763000428723 DEN120017 000
00763000624804 DEN120017 000
00763000624798 DEN120017 000
00763000624781 DEN120017 000
00763000624774 DEN120017 000
00763000624767 DEN120017 000
00763000624750 DEN120017 000
00763000624743 DEN120017 000
00763000428730 DEN120017 000
00763000428747 DEN120017 000
00763000428754 DEN120017 000
00763000406028 DEN120017 000
00763000406011 DEN120017 000
00763000406004 DEN120017 000
00763000395971 DEN120017 000
20763000431277 DEN120017 000
00763000428785 DEN120017 000
00763000428778 DEN120017 000
00763000428761 DEN120017 000
00763000281267 DEN120017 000

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