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: MELODY TRANSCATHETER PULMONARY VALVE
• Applicant: Medtronic, Inc; 8200 coral sea street ne mvs83; mounds view, MN 55112
• HDE Number: H080002
• Supplement Number: S005
• Date Received: 07/28/2011
• Decision Date: 08/25/2011
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change - manufacturer/sterilizer/packager/supplier
• Expedited Review Granted?: No
• Combination Product: No