PREVENA 125 And PREVENA PLUS 125 Therapy Units


The following data is part of a De Novo classification by Kci Usa, Inc. with the FDA for Prevena 125 And Prevena Plus 125 Therapy Units.

Pre-market Notification Details

DeNovo IDDEN180013
Device Name:PREVENA 125 And PREVENA PLUS 125 Therapy Units
Applicant KCI USA, Inc. 6203 Farinon Drive San Antonio,  TX  78249
ContactKimberly Mccoy
Product CodeQFC
DecisionGranted (DENG)
Review Advisory BoardGeneral & Plastic Surgery
Date Received2018-03-15
Decision Date2019-04-19

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