|Trade Name||AMPLATZER SEPTAL OCCLUDER AND AMPLATZER MULTI-FENESTRATED 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 an alternate source of routine bioburden and sterility testing, as well as changes to the bioburden testing protocol.