Yahoo Finance

Practical Guide to FDA Medical Device Submissions: 510(k), PMA and Exemption Pathways (WEBINAR)

Dublin, April 15, 2026 (GLOBE NEWSWIRE)-- The "Practical Guide to FDA Medical Device Submissions - 510(k), PMA and Exemption Pathways (Apr 14, 2026)" training has been added to ...
Nasdaq

United Health Products Provides Update on FDA PMA Application Process

MOUNT LAUREL, NJ - (NewMediaWire) - June 24, 2024 - United Health Products, Inc. (OTCPK: UEEC) today provided an update on the company's FDA Premarket Approval (PMA) application process. Following the ...
MD&M East

Abiomed’s Impella 2.5 Wins PMA Approval

Impella 2.5, the main product for Danvers, MA-based Abiomed Inc., has received FDA premarket approval (PMA) for use in elective and urgent high-risk percutaneous coronary intervention (PCI) procedures ...
Raleigh News & Observer

enVVeno Medical Submits the VenoValve PMA Application Seeking FDA Approval

Definitive One Year Data from PMA Application to be Presented Wednesday at 51st Annual VEITH Symposium Company to Host a Conference Call with the PIs Presenting the Pivotal Trial Data on Wednesday, ...
RAPS

PMA Denials: Why so Few?

In the pharmaceutical industry, complete response letters, or rejections, are a common occurrence. And though they aren’t frequently explained in detail publicly, the public is still usually notified ...
Seeking Alpha

United Health Products Reiterates Guidance on FDA PMA Application Process

MESQUITE, NV, June 07, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – United Health Products, Inc. (UEEC) today provided an update on the company’s FDA Premarket Approval application process. As ...