|Trade Name||AMPLATZER SEPTAL OCCLUDER|
|Classification Name||occluder, patent ductus, arteriosus|
|Applicant||AGA MEDICAL CORP.|
|Supplement Type||real-time process|
|Supplement Reason|| process change: packaging|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modifications to the device packaging and inclusion of a three year shelf life for the original amplatzer duct occluder and septal occluder delivery and exchange systems.