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 IIb, sponsor KCI…

Intended purpose

When used on open wounds, the 3M™ V.A.C.® Granufoam™ Dressing Kit with the 3M™ V.A.C.® 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 edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types are: acute and subacute dehisced wounds, traumatic wounds, partial-thickness burns, flaps, grafts and chronic diabetic ulcers, pressure ulcers and venous insufficiency ulcers. When used on closed surgical incisions, the 3M™ V.A.C.® Granufoam™ Dressing Kit is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. The 3M™ V.A.C.® Granufoam™ Dressing Kit is compatible with the following therapy systems: · 3M™ V.A.C.® Ulta Negative Pressure Wound Therapy System · 3M™ V.A.C.® Rx4 Negative Pressure Wound Therapy System · 3M™ ActiV.A.C.™ Negative Pressure Wound Therapy System · 3M™ V.A.C.® Simplicity Negative Pressure Wound Therapy System · 3M™ Prevena™ Plus Negative Pressure Wound Therapy System The 3M™ V.A.C.® Ulta and 3M™ V.A.C.® Rx4 Therapy Systems are integrated negative pressure wound management systems for use in acute care settings and other professional healthcare environments where product use is conducted by or under the supervision of a qualified healthcare professional. The 3M™ ActiV.A.C.™, 3M™ V.A.C.® Simplicity and 3M™ Prevena™ Plus Negative Pressure Wound Therapy Systems are integrated negative pressure wound management systems for use in acute, extended and home care settings.

TGA Public Summary