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: EXCOR PEDIATRIC VENTRICULAR ASSIST DEVICE
• Applicant: Berlin Heart, Inc.; 200 valleywood; suite b100; the woodlands, TX 77380
• HDE Number: H100004
• Supplement Number: S005
• Date Received: 04/06/2012
• Decision Date: 05/17/2012
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change - manufacturer/sterilizer/packager/supplier
• Expedited Review Granted?: No
• Combination Product: No