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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
Applicant
Boston Scientific Corporation
300 boston scientific way
marlborough, MA 01752
HDE NumberH980006
Supplement NumberS024
Date Received03/09/2012
Decision Date03/29/2012
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 ProductYes
Approval Order Statement 
Approval for changes in administ111ration set, including replacement with new injection syringe, easily operating tube pinch clamp, and tighten the acceptable radiation range for sterilization to 25-35 gy. , and is indicated for treatment of unresectable hepatocellular carcinoma (hcc).
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