United States Food and Drug Administration perspectives on the update to the objective performance criteria for surgically implanted heart valve prostheses
Ann Thorac Surg. 2014 Nov;98(5):1890-1.
doi: 10.1016/j.athoracsur.2014.09.008.
Epub 2014 Oct 30.
1 Division of Cardiovascular Devices, Office of Device Evaluation, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD 20993. Electronic address: [email protected].
2 Division of Cardiovascular Devices, Office of Device Evaluation, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD 20993.
3 Division of Biostatistics, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD 20993.