|Trade Name||THE AMPLATZER SEPTAL OCCLUDER|
|Classification Name||occluder, patent ductus, arteriosus|
|Applicant||AGA MEDICAL CORP.|
|Supplement Type|| Special Supplement|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for labeling changes to address reported adverse events such as tissue erosion/perforation and device embolization.