As part of its substantive review process to evaluate UHP's PMA (Pre-market Approval) application, the FDA has requested details on certain elements of the HemoStyp manufacturing process. In keeping with industry best practices, UHP recently completed the implementation of an industry-standard Good Manufacturing Practices (GMP) software tool and will be submitting a response to the
Separately, UHP's registration statement was declared effective by the
As part of its ongoing R&D effort, UHP recently produced a prototype form of HemoStyp material that is designed for trauma and surgical applications where its existing HemoStyp gauze material may not be suitable. Further in-vitro and animal testing is planned to advance potential FDA and other regulatory applications for use of this format.
UHP will host an update call on
https://us06web.zoom.us/j/5578590134
Meeting ID: 557 859 0134
Telephonic access: +1 929.205.6099 - Mtg ID 5578590134#
To register for this Zoom session, please email UHP at info@unitedhealthproductsinc.com and include your name, telephone number, email address and country of residency.
As previously disclosed, UHP's Class III PMA application is currently in Substantive Review by the FDA. Receipt of a PMA will allow marketing of HemoStyp products for human surgical procedures. There can be no assurance that the PMA will be granted by the FDA.
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