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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
Classification Namemicrospheres radionuclide
Generic Namemicrospheres radionuclide
Boston Scientific Corporation
300 boston scientific way
marlborough, MA 01752
HDE NumberH980006
Supplement NumberS034
Date Received10/05/2016
Decision Date12/12/2016
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 an addition of the australian nuclear science and technology organization (ansto) with the open pool australian ligh-water (opal) research nuclear reactor, located at lucas height, new south wales, australia to currently approved 3 other nuclear reactor to irradiate y-89 in the therasphere ampules to convert into y-90 beta emitting radioisotopes.