Device Dossier

Negative-pressure wound therapy system foam dressing

Device Dossier for Negative-pressure wound therapy system foam dressing (Negative-pressure wound therapy system foam dressing, Class IIa, sponsor KCI…

Intended purpose

The Prevena™ Incision Management System is intended to manage the environment of closed surgical incisions and surrounding intact skin in patients at risk for developing post-operative complications, such as infection, by maintaining a closed environment via the application of a negative pressure wound therapy system to the incision. The Prevena™ Incision Dressing skin interface layer with silver reduces microbial colonization in the fabric.

TGA Public Summary