United Health Products, Inc. (OTCPK: UEEC), (UHP) today provided an update on the status of its application to the Food & Drug Administration (FDA) for Pre-market Approval (PMA) of its HemoStyp™ hemostatic gauze. On Dec. 21, the FDA informed UHP that its review of the PMA application is ongoing and at this time there were no additional information requests to UHP. The FDA reserves the right under its review process to request additional information at any time.
As previously disclosed, UHP's PMA application is currently in Substantive Review by the FDA. Receipt of a PMA is a condition to the company's ability to market its HemoStyp products for human surgical procedures in the United States. There can be no assurance that a PMA will be granted by the FDA.
About United Health Products -- United Health Products develops, manufactures and markets HemoStyp, a patented Neutralized Oxidized Regenerated Cellulose (NORC) hemostatic agent. HemoStyp is an all-natural product designed to control bleeding. UHP currently offers a suite of hemostatic products to the dental, veterinary and consumer markets, and is focused on gaining approval to access the human surgical market.
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Original Source: United Health Products Provides Regulatory Status Update