De Novo DEN120017

Device
Medtronic DUET External Drainage and Monitoring System
Contact
donovan may
De Novo number
DEN120017
Product code
PCB
Regulation
882.5560
Classification name
external cerebrospinal fluid (csf) diversion
Decision
granted (DENG)
Decision date
2014-08-22
Date received
2012-12-21
Classification advisory
Neurology
Review advisory
Neurology
Type
Post-NSE

Current FDA Classification#

Product code
PCB
Device name
External Cerebrospinal Fluid (Csf) Diversion
Medical specialty
Neurology
Device class
2
Regulation
882.5560
Implant
N
Life sustain/support
N