United Health Products Submits Full FDA PMA Application

Rhea-AI Summary

United Health Products, Inc. (UEEC) updates on FDA Premarket Approval application for absorbable hemostatic gauze.

MOUNT LAUREL, NJ, March 21, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire -- United Health Products, Inc. (OTCPK: UEEC) today provided an update on the company’s FDA Premarket Approval application process.  

The company confirms that it has submitted via the FDA eSTAR portal its Premarket Approval (PMA) application for its absorbable hemostatic gauze, which will now be reviewed by the FDA and Health Canada. Information on the FDA review process for PMA applications can be found on the FDA website at:

https://www.fda.gov/medical-devices/premarket-approval-pma/pma-review-process

There can be no assurance that the company’s PMA or Health Canada applications will be approved.

About United Health Products -- UHP develops, manufactures and markets HemoStyp™, a patented Neutralized Regenerated Cellulose 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 emergency medicine markets, and is seeking approval to access the human surgical market. 

For more information on UHP visit the company’s new website: www.uhpcorp.com or contact the company at info@uhpcorp.com.

The company can also be reached by phone or text message at 475.755.1005

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This news release may contain forward-looking information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements that include the words "believes," "expects," "anticipates" or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the company to differ materially from those expressed or implied by such forward-looking statements.

FAQ

What update did United Health Products, Inc. provide?

United Health Products, Inc. provided an update on the company’s FDA Premarket Approval application process.

What application did United Health Products, Inc. submit?

United Health Products, Inc. submitted its Premarket Approval (PMA) application for its absorbable hemostatic gauze.

Where did United Health Products, Inc. submit the application?

United Health Products, Inc. submitted the application via the FDA eSTAR portal.

Who will review the application?

The application will be reviewed by the FDA and Health Canada.

Is there a guarantee of approval for the applications?

There is no assurance that the company’s PMA or Health Canada applications will be approved.