Search Results

MacroPro Cream may be used to aid in the management of superficial and partial thickness burns; pressure ulcers (stages I-IV); venous, diabetic, and arterial ulcers; donor graph sites; superficial through full thickness wounds such as surgical wounds, minor abrasions and lacerations; and irritations of the skin.

MacroPro Cream provides a moist environment which supports in the autolytic debridement of wounds with scattered areas of necrosis and slough.

For external use only. Do not use on patients with known allergies to plants such as gum oat.

Brennen Medical Beta Glucan Cream, "MacroPro"

This document is a Premarket Notification (510(k)) decision letter from the FDA for the "Brennen Medical Beta Glucan Cream, 'MacroPro'". It focuses on regulatory approval and substantial equivalence, not on the performance of the device against specific acceptance criteria from a clinical study.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be extracted from the provided text. The document does not describe any specific performance criteria, a study design, sample sizes, expert qualifications, or ground truth establishment related to the device's efficacy or safety. It primarily outlines the allowed indications for use and disclaimers for labeling.

Ask a specific question about this device