|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||AMPLATZER SEPTAL OCCLUDER|
|Classification Name||occluder, patent ductus, arteriosus|
|Applicant||AGA MEDICAL CORP.|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Modifications to pouch sealing equipment.