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: S016
• Date Received: 01/26/2011
• Decision Date: 02/18/2011
• Product Code: MLV [ Registered Establishments with MLV ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Use of new patch forming equipment.