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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 NumberS036
Date Received02/22/2017
Decision Date03/02/2017
Product Code
NAW[ Registered Establishments with NAW ]
Advisory Committee Radiology
Supplement Typenormal 75 day track
Supplement Reason request for adn
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for increasing the adn to reflect the change of threshold for humanitarian device exemptions to up to 8,000 patients, and for applying the adn multiplier of 1. 8 to the 8,000 patients, which equates to an adn of 14,400 doses.
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