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: MDS NORDION THERASPHERE YTTRIUM-90 GLASS MICROSPHERES
• Classification Name: microspheres radionuclide
• Generic Name: microspheres radionuclide
• Applicant: Boston Scientific Corporation; 300 boston scientific way; marborough, MA 01752
• HDE Number: H980006
• Supplement Number: S004
• Date Received: 08/16/2001
• Decision Date: 09/19/2001
• Product Code: NAW [ Registered Establishments with NAW ]
• Advisory Committee: Radiology
• Supplement Type: normal 75 day track
• Supplement Reason: change design/components/specifications/material
• Expedited Review Granted?: No
• Combination Product: No