First Food and Drug Administration approval under humanitarian device exemption of a septal occluder for fenestrated fontan and muscular ventricular septal defects.
Ruiz
C E
CE
Department of Pediatric Interventional Cardiology, Rush-Presbyterian-St. Luke's Medical Center, Chicago, IL 60612-3833, USA.
Austin
E H
EH
Cheatham
J P
JP
Danford
D A
DA
Latson
L A
LA
Mayer
J
J
Mullins
C E
CE
Sanders
S
S
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