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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 NumberS019
Date Received04/21/2011
Decision Date06/24/2011
Product Code
NAW[ Registered Establishments with NAW ]
Advisory Committee Radiology
Supplement Typenormal 75 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for changes in the package insert to improve the safe infusion process using hemostat to prevent the saline leakage. Correction of the isotope decay table for moreaccurate dlosimetry, correction of device administration flow rate to greater than 20 cc per minute. Other minor changes of optional items, and notifying the change of company's name to nordion (canada), inc.
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