A new paradigm for obtaining marketing approval for pediatric-sized prosthetic heart valves.

Yoganathan, Ajit P

A new paradigm for obtaining marketing approval for pediatric-sized prosthetic heart valves. [electronic resource] - The Journal of thoracic and cardiovascular surgery Oct 2013 - 879-86 p. digital

Publication Type: Journal Article

1097-685X

10.1016/j.jtcvs.2013.04.016 doi


Adolescent
Age Factors
Child
Child, Preschool
Device Approval--standards
Equipment Failure Analysis
Heart Defects, Congenital--surgery
Heart Valve Prosthesis--standards
Heart Valve Prosthesis Implantation--instrumentation
Heart Valves--abnormalities
Humans
Infant
Infant, Newborn
Marketing of Health Services--standards
Materials Testing
Practice Guidelines as Topic
Product Surveillance, Postmarketing
Prosthesis Design
Prosthesis Failure
United States
United States Food and Drug Administration--standards