title: First Food and Drug Administration approval under humanitarian device exemption of a septal occluder for fenestrated fontan and muscular ventricular septal defects.
authors.affiliation: Department of Pediatric Interventional Cardiology, Rush-Presbyterian-St. Luke's Medical Center, Chicago, IL 60612-3833, USA.
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: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D018795:Device Approval / Q000592:standards; D004864:Equipment and Supplies; D018729:Fontan Procedure / Q000379:methods*; D006345:Heart Septal Defects, Ventricular / Q000601:surgery*; D006801:Humans; D007223:Infant; D014481:United States; D014486:United States Food and Drug Administration