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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 NumberS011
Date Received06/23/2006
Decision Date11/14/2006
Product Code
NAW[ Registered Establishments with NAW ]
Advisory Committee Radiology
Supplement Typenormal 75 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for removal of partial or branch occlusion, or thrombosis of portal veins from the contraindications, and for retaining the total occlusion of the main portalvein in the contraindications. It is additionally indicated for patients with hepatocellular carcinoma, who have partial or branch occlusion of portal veins, when clinical evaluation warrants the treatment.
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