title: United States Food and Drug Administration perspectives on the update to the objective performance criteria for surgically implanted heart valve prostheses.
authors.affiliation: 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: Changfu.Wu@fda.hhs.gov.
authors.forename: Changfu
authors.initials: C
authors.lastname: Wu
authors.affiliation: Division of Cardiovascular Devices, Office of Device Evaluation, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD 20993.
authors.forename: Steven B
authors.initials: SB
authors.lastname: Kurtzman
authors.affiliation: Division of Cardiovascular Devices, Office of Device Evaluation, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD 20993.
authors.forename: John
authors.initials: J
authors.lastname: Laschinger
authors.affiliation: Division of Biostatistics, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD 20993.
authors.forename: Terri
authors.initials: T
authors.lastname: Johnson
authors.affiliation: Division of Cardiovascular Devices, Office of Device Evaluation, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD 20993.
authors.forename: Fernando
authors.initials: F
authors.lastname: Aguel
mesh_terms: D006349:Heart Valve Diseases / Q000601:surgery*; D006350:Heart Valve Prosthesis; D006801:Humans