FDA.reportPublic FDA data

De Novo DEN180013

Device
PREVENA 125 and PREVENA PLUS 125 Therapy Units
Contact
kimberly mccoy
De Novo number
DEN180013
Product code
QFC
Regulation
878.4783
Classification name
negative pressure wound therapy device for reduction of wound complications
Decision
granted (DENG)
Decision date
2019-04-19
Date received
2018-03-15
Classification advisory
General & Plastic Surgery
Review advisory
General & Plastic Surgery
Type
Direct

Current FDA Classification#

Product code
QFC
Device name
Negative Pressure Wound Therapy Device For Reduction Of Wound Complications
Medical specialty
General, Plastic Surgery
Device class
2
Regulation
878.4783
Implant
N
Life sustain/support
N