A Stopping Guideline for Pulmonary Heart Valve Premarket Approval Studies

MeSH terms

• Bayes Theorem
• Clinical Trials Data Monitoring Committees / standards*
• Device Approval / standards*
• Guideline Adherence / standards*
• Heart Valve Prosthesis Implantation / adverse effects
• Heart Valve Prosthesis Implantation / instrumentation*
• Heart Valve Prosthesis*
• Humans
• Postoperative Complications / etiology
• Practice Guidelines as Topic / standards*
• Prosthesis Design
• Pulmonary Valve / transplantation*
• Risk Factors
• Time Factors
• Treatment Outcome
• United States
• United States Food and Drug Administration / standards*