|Trade Name||AMPLATZER SEPTAL OCCLUDER AND AMPLATZER MULTIFENESTRATED SEPTAL OCCLUDER-CRIBRIFORM|
|Classification Name||occluder, patent ductus, arteriosus|
|Applicant||AGA MEDICAL CORP.|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for aga medical corporation to become the primary source for the laser welding process, while retaining the current vendor as a secondary source.