Medical Device

United Health Products (OTCPK:UEEC), manufacturer and marketer of HemoStyp®, a patented hemostatic gauze for the healthcare and wound care sectors, today announced that, following a face-to-face meeting between FDA and key UHP representatives, it will pursue its PMA class III filing under the FDA’s CtQ Pilot program for use in internal surgical procedures. As quoted in …

United Health Products (OTCPK:UEEC), manufacturer and marketer of HemoStyp®, a patented hemostatic gauze for the healthcare and wound care sectors, today announced that, following a face-to-face meeting between FDA and key UHP representatives, it will pursue its PMA class III filing under the FDA’s CtQ Pilot program for use in internal surgical procedures.
As quoted in the press release:

Further, the company has decided to withdraw from its class II extension of use application with the FDA. It was determined that the PMA application allows a much broader range of indication than the prior 510K class II of expanded usage.

Click here to read the full press release.

 

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