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: EXCORIM IMMUNOADSORPTION SYSTEM
• Classification Name: columns, immunoadsorption in extracorporeal systems
• Generic Name: columns, immunoadsorption in extracorporeal systems
• Applicant: Fresenius Medical Care; 95 hayden ave.; lexington, MA 02420
• HDE Number: H970004
• Supplement Number: S011
• Date Received: 05/02/2006
• Decision Date: 10/03/2006
• Product Code: LQQ
• Advisory Committee: Gastroenterology
• Supplement Type: normal 75 day track
• Supplement Reason: process change - manufacturer/sterilizer/packager/supplier
• Expedited Review Granted?: No
• Combination Product: No