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 MUSCULAR VSD OCCLUDER
• Classification Name: transcatheter septal occluder
• Generic Name: device transcatheter cardiac occlusion
• Applicant: AGA MEDICAL CORP.
• PMA Number: P040040
• Supplement Number: S007
• Date Received: 12/09/2008
• Decision Date: 01/08/2009
• Product Code: MLV [ Registered Establishments with MLV ]
• Advisory Committee: Cardiovascular
• Supplement Type: Special Supplement
• Supplement Reason: labeling change - instructions
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for modifications to the labeling regrading aspirin dosing.