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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 NameTheraSphere Y-90 Glass Microspheres
Classification Namemicrospheres radionuclide
Generic Namemicrospheres radionuclide
Applicant
Boston Scientific Corporation
300 boston scientific way
marlborough, MA 01752
HDE NumberH980006
Supplement NumberS038
Date Received12/01/2017
Decision Date01/16/2018
Product Code
NAW[ Registered Establishments with NAW ]
Advisory Committee Radiology
Supplement Typenormal 75 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for adding the high flux reactor (hfr) operated by nrg in petten, the netherlands, as an additional ampoule irradiator site for therasphere y-90 glass microspheres.
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