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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
marborough, MA 01752
HDE NumberH980006
Supplement NumberS016
Date Received04/09/2009
Decision Date02/28/2014
Product Code
NAW[ Registered Establishments with NAW ]
Advisory Committee Radiology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for an update in the instructions for use section of the therasphere package insert.
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