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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 NumberS012
Date Received11/28/2006
Decision Date02/16/2007
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 a change in construction of cover plate on the dose k vial in order to prevent leakage, changes in package insert to include an additional adverse event,a new adverse event table, deleting an obsolete imaging modality from the list of required procedures in the preliminary patient evaluation, and other minor changes to provide improved description of the infusion assembly.
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