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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 NumberS002
Date Received02/15/2001
Decision Date03/06/2001
Product Code
NAW[ Registered Establishments with NAW ]
Advisory Committee Radiology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Increase in the quantity of glass microspheres to be irradiated from 1. 5g to 2. 5g to accommodate production scale-up.
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