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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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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 NameMDS NORDION THERASPHERE YTTRIUM-90 GLASS MICROSPHERES
Classification Namemicrospheres radionuclide
Generic Namemicrospheres radionuclide
Applicant
Boston Scientific Corporation
300 boston scientific way
marlborough, MA 01752
HDE NumberH980006
Supplement NumberS014
Date Received04/07/2008
Decision Date06/24/2008
Product Code
NAW[ Registered Establishments with NAW ]
Advisory Committee Radiology
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for replacement of the administration set and administration accessory kit with a new redesigned administration set and accessory kit; and, forelimination of the needle guide assembly. It is indicated for necoadjuvant to surgery or transplantation in patients with unresectable hepatocellular carcinoma, who can have placement of an appropriately positioned, hepatic arterial catheter.
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