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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameMDS NORDION THERASPHERE YTTRIUM-90 GLASS MICROSPHERES
Classification Namemicrospheres radionuclide
Generic Namemicrospheres radionuclide
Applicant
BIOCOMPATIBLES U.K. LIMITED
chapman house, farnham bus.
park, weydon ln
farnham, surrey england GU9 8
HDE NumberH980006
Date Received08/11/1998
Decision Date12/10/1999
Product Code
NAW[ Registered Establishments with NAW ]
Docket Number 99M-5539
Advisory Committee Radiology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Therasphere(r) is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable hepatocellular carcinoma (hcc) who can have placement of appropriately positioned hepatic arterial catheters.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S008 S009 S011 
S012 S013 S014 S015 S016 S017 S019 S021 S023 
S024 S025 S026 S027 S029 S030 S031 S032 S033 
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