First FDA approval under humanitarian device exemption of a septal occluder for fenestrated fontan and muscular ventricular septal defects.
Ruiz
C E
CE
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
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