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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
marborough, MA 01752
HDE NumberH980006
Supplement NumberS027
Date Received04/14/2014
Decision Date10/15/2014
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 in accordance with 613(b) of the food and drug administration safety and innovation act (fdasia), a determination that the humanitarian use device (hud) meets the conditions of either subclause (i) or (ii) under section 520(m)(6)(a)(i) of the federal food, drug, and cosmetic act (fd&c act), as amended by the fdasia, so that the device may be sold for an amount that exceeds the costs of research and development, fabrication, and distribution of the device (i. E. , for profit). The adn for this device has been determined to be 1. 8 x 4000 = 7200 vials.
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