title: First FDA approval under humanitarian device exemption of a septal occluder for fenestrated fontan and muscular ventricular septal defects.
authors.forename: C E
authors.initials: CE
authors.lastname: Ruiz
authors.forename: E H
authors.initials: EH
authors.lastname: Austin
authors.forename: J P
authors.initials: JP
authors.lastname: Cheatham
authors.forename: D A
authors.initials: DA
authors.lastname: Danford
authors.forename: L A
authors.initials: LA
authors.lastname: Latson
authors.forename: J
authors.initials: J
authors.lastname: Mayer
authors.forename: C E
authors.initials: CE
authors.lastname: Mullins
authors.forename: S
authors.initials: S
authors.lastname: Sanders
mesh_terms: D006348:Cardiac Surgical Procedures; D018795:Device Approval; D006345:Heart Septal Defects, Ventricular / Q000601:surgery*; D006801:Humans; D019736:Prostheses and Implants; D014481:United States; D014486:United States Food and Drug Administration