3M™ Prevena™ Plus 125 Therapy Unit with 3M™ Prevena™ Plus 150mL Canister - Negative-pressure wound therapy system, battery-powered, single-use

Risk Class

Class IIa

Product Type

Medical device system

ARTG Category

General

Start Date

May 09, 2024

Effective Date

May 09, 2024

Name

KCI Medical Australia Pty Ltd

Name

KCI USA Inc

Country

United States of America

Address

12930 IH 10 West, San Antonio, TX, 78249

The 3M™ Prevena™ Plus 125 Therapy Unit, when used with the 3M™ Prevena™ Dressings (3M™ Prevena™ Plus 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 3M™ Prevena™ Plus 125 Therapy Unit, when used with compatible 3M™ V.A.C.® Dressings on open wounds (3M™ Prevena™ Plus negative Pressure Wound Therapy System), is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing oedema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include chronic, acute, traumatic, subacute, and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure, or venous insufficiency), flaps and grafts.