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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 NumberS031
Date Received04/15/2015
Decision Date12/18/2015
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 the addition of b. Braun medical, inc. , allentown, pa 18109, usa (b. Braun) as an alternate supplier. The b. Braun set has a shelf life of 3 years, uses terminal sterilization by ethylene oxide, and has minor differences in components and materials of composition of the set: tubing, luer fittings, valves, etc. The b. Braun set has a clear protective cap on vented spike. In addition, a new pinch clamp is proposed to replace user-supplied hemostat in both b. Braun set and the existing cea set.
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