Premarket Approval (PMA)

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: THE AMPLATZER SEPTAL OCCLUDER
• Classification Name: occluder, patent ductus, arteriosus
• Applicant: AGA MEDICAL CORP.
• PMA Number: P000039
• Supplement Number: S015
• Date Received: 01/23/2006
• Decision Date: 02/22/2006
• Product Code: MAE [ Registered Establishments with MAE ]
• Advisory Committee: Cardiovascular
• Supplement Type: Special Supplement
• Supplement Reason: labeling change - instructions
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for labeling changes to address reported adverse events such as tissue erosion/perforation and device embolization.