Food and Drug Administration commentary on "a new paradigm for obtaining marketing approval for pediatric-sized prosthetic heart valves"

J Thorac Cardiovasc Surg. 2013 Oct;146(4):887. doi: 10.1016/j.jtcvs.2013.06.003. Epub 2013 Jul 16.

Authors

Fernando Aguel¹, Steven B Kurtzman, Sonna Patel-Raman, Matthew Hillebrenner, Bram D Zuckerman

Affiliation

¹ Division of Cardiovascular Devices, Office of Device Evaluation, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Md. Electronic address: fernando.aguel@fda.hhs.gov.

PMID: 23870153
DOI: 10.1016/j.jtcvs.2013.06.003

No abstract available

Keywords: 20; 35; 35.3; 4.2.

Publication types

Editorial
Comment

MeSH terms

Device Approval*
Heart Defects, Congenital / surgery*
Heart Valve Prosthesis Implantation / instrumentation*
Heart Valve Prosthesis*
Heart Valves / surgery*
Humans
Marketing of Health Services*
United States Food and Drug Administration*