Humanitarian Device Exemption (HDE)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device.

• Trade Name: AMPLATZER PFO OCCLUDER
• Classification Name: transcatheter septal occluder
• Generic Name: transcatheter septal occluder
• Applicant: Aga Medical Corp.; 682 mendelssohn ave.; plymouth, MN 55427
• HDE Number: H000007
• Supplement Number: S005
• Date Received: 02/02/2004
• Decision Date: 09/16/2005
• Product Code: MLV [ Registered Establishments with MLV ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change - manufacturer/sterilizer/packager/supplier
• Expedited Review Granted?: No
• Combination Product: No