De Novo DEN170018

Device
NSS-2 System
Contact
tom carrico
De Novo number
DEN170018
Product code
PZR
Regulation
882.5896
Classification name
percutaneous nerve stimulator for opioid withdrawal
Decision
granted (DENG)
Decision date
2017-11-15
Date received
2017-03-17
Classification advisory
Neurology
Review advisory
Neurology
Type
Direct

Current FDA Classification#

Product code
PZR
Device name
Percutaneous Nerve Stimulator For Opioid Withdrawal
Medical specialty
Neurology
Device class
2
Regulation
882.5896
Implant
N
Life sustain/support
N