Allied submits 510(k) application for heart tissue device

04/10/2013 | MassDevice.com (Boston)

Allied Healthcare Group has filed an application with the FDA for 510(k) clearance for its CardioCel tissue patch. The device, which is used to treat malfunctioning heart valves and cardiac deformities, already has been approved in Australia and is awaiting CE mark approval in Europe.

View Full Article in:

MassDevice.com (Boston)

Published in Briefs:

SmartBrief Job Listings for Health Care

Job Title Company Location
Director, Senior Legal Counsel
Alcon
Fort Worth, TX
Associate Director, Compliance Business Partner I
Boehringer Ingelheim
Ridgefield, CT
Attorney
U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration Office of the Chief Counsel
Silver Spring, MD, MD
Counsel – Regulatory Affairs
RAI Services Company
Winston Salem, NC
Senior Manager, Clinical Affairs - Advanced Technology
Edwards Lifesciences
Irvine, CA