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: CONTEGRA PULMONARY VALVED CONDUIT
• Applicant: Medtronic, Inc.; 1851 e. deere ave.; santa ana, CA 92705
• HDE Number: H020003
• Supplement Number: S006
• Date Received: 07/31/2008
• Decision Date: 09/04/2008
• Advisory Committee: Cardiovascular
• Supplement Type: special (immediate track)
• Supplement Reason: labeling change - indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No