United Health Products Announces Submission of Premarket Approval (PMA) Application to the U.S. FDA for the HemoStyp® Device for Use in Surgical Procedures
HENDERSON, Nev., Oct. 04, 2019 (GLOBE NEWSWIRE) -- United Health Products, Inc. (UHP) (OTC: UEEC) today announced that it has submitted a Premarket Approval (PMA) application for Class III approval to the FDA for HemoStyp.
The PMA program confirms the safety and efficacy of a product. If approved, UHP expects that HemoStyp will be authorized for use in surgical procedures in abdominal, cardiovascular, thoracic and vascular surgeries per UHP’s PMA filed Instructions For Use. HemoStyp’s PMA application falls under SUBCHAPTER H--MEDICAL DEVICES PART 878 -- GENERAL AND PLASTIC SURGERY DEVICES. Subpart E--Surgical Devices Sec. 878.4490 Absorbable hemostatic agent and dressing. An absorbable hemostatic agent or dressing is a device intended to produce hemostasis by accelerating the clotting process of blood. It is absorbable; is intended for internal surgical use; and, is classified as a Class III device.
About United Health Products
UHP develops, manufactures, and markets patented hemostatic gauze for the healthcare and wound care sectors. Its proprietary product, HemoStyp®, is derived from regenerated oxidized cellulose, which is all natural, is designed to absorb exudate/drainage from superficial wounds, and helps control bleeding. UHP is focused on identifying new markets and applications for its products, and expanding its current markets. For more on UHP visit: www.unitedhealthproductsinc.com
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