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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 NumberS006
Date Received12/17/2003
Decision Date01/09/2004
Product Code
NAW[ Registered Establishments with NAW ]
Advisory Committee Radiology
Supplement Type30-day notice
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Change in administration set for the therasphere yttrium-90 microspheres to be manufacturered with the needles approved in supplement 5 and withoutredundant syringe.
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