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: AMPLATZER SEPTAL OCCLUDER AND AMPLATZER EXCHANGE SYSTEM
• Classification Name: occluder, patent ductus, arteriosus
• Applicant: AGA MEDICAL CORP.
• PMA Number: P000039
• Supplement Number: S035
• Date Received: 03/23/2010
• Decision Date: 04/22/2010
• Product Code: MAE [ Registered Establishments with MAE ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change - other
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Addition of an alternate component supplier.