United Health Products Provides Update on FDA PMA Application
UNITED HEALTH PRODUTS INC (UEEC)
NASDAQ:AMEX Investor Relations:
unitedhealthgroup.com/investors.aspx
Company Research
Source: GlobeNewswire
MOUNT LAUREL, N.J., Nov. 04, 2024 (GLOBE NEWSWIRE) -- United Health Products, Inc. (OTCPK: UEEC) today provided an update on the company’s FDA Premarket Approval (PMA) application process. Following the company’s August 15, 2024 submission of its Submission Issue Request (SIR) to the FDA which responded to certain questions in the FDA’s June 18 letter and described the company’s approach to addressing certain FDA-identified deficiencies in its PMA application, the company held a videoconference with the FDA on October 29. The purpose of the meeting was to present, discuss and seek feedback from the FDA on the company’s proposed resolutions to the deficiencies. Topics discussed include the company’s clinical testing (including the results of its human trial), biocompatibility, product sterilization and shelf life. This meeting has provided the company with certainty on how to address the deficiencies, with many of the issues already having been resolved. During the discussion, the
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Sec Filings
- 11/12/24 - Form 10-Q
- 11/6/24 - Form 8-K
- UEEC's page on the SEC website