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
• Classification Name: occluder, patent ductus, arteriosus
• Applicant: AGA MEDICAL CORP.
• PMA Number: P000039
• Supplement Number: S037
• Date Received: 11/12/2010
• Decision Date: 01/04/2011
• Product Code: MAE [ Registered Establishments with MAE ]
• Advisory Committee: Cardiovascular
• Supplement Type: normal 180 day track no user fee
• Supplement Reason: postapproval protocol or modification to a protocol
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval of the post-approval study protocol.