Seeking Alpha

United Health Products Submits Full FDA PMA Application

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

FDA Offers New Insight on When to Submit PMA Supplements for Device Manufacturer Site Changes

Medical device companies trying to understand what officially constitutes a manufacturing site change and when to submit a premarket approval (PMA) supplement will want to consult with draft guidance ...
Seeking Alpha

United Health Products Provides Update on FDA PMA Application and Amendment to White Lion Agreement

Mesquite, NV, Jan. 31, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire -- United Health Products, Inc. (OTCPK: UEEC), (UHP) today provided an update on the company’s FDA Premarket Approval application ...

Adagio Medical seeks FDA PMA for ventricular ablation system

The application draws on data from the FULCRUM-VT pivotal IDE trial, which enrolled 209 patients across 20 centres.
MassDevice

Adagio submits ventricular ablation system to FDA

Adagio Medical (Nasdaq:ADGM) announced today that it submitted its premarket approval (PMA) application to the FDA for its ...