Comparison of the investigational device exemption and post-approval trials of the Melody transcatheter pulmonary valve

Jacqueline Kreutzer, Aimee K. Armstrong, Jonathan J. Rome, Thomas M. Zellers, David T. Balzer, Jeffrey D. Zampi, Allison K. Cabalka, Alexander J. Javois, Daniel R. Turner, Robert G. Gray, John W. Moore, Shicheng Weng, Thomas K. Jones, Danyal M. Khan, Julie A. Vincent, William E. Hellenbrand, John P. Cheatham, Lisa J. Bergersen, Doff B. McElhinney