United Health to submit full PMA application following sample analysis review

United Health Products provides an update on the company’s FDA Premarket Approval application. UHP continues to advance its Premarket Approval application with the Food and Drug Administration. As described in its October 31 press release, the company has completed its review and documentation of manufacturing and packaging related Standard Operating Procedures and is now awaiting external laboratory test results on HemoStyp samples produced under its new manufacturing arrangement. Upon receipt and review of the sample analysis, the company expects to submit its full PMA application within a few days. There can be no assurance that the company’s PMA application will be approved.