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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 NameLIXELLE® ß2-microgliblin Apheresis Column
Classification Namebeta 2-microglobulin apheresis column
Generic Namebeta 2-microglobulin apheresis column
Applicant
Kaneka Pharma America, LLC
546 fifth ave., 21st floor
new york, NY 10036
HDE NumberH130001
Supplement NumberS003
Date Received03/10/2023
Decision Date12/18/2023
Product Code
PDI[ Registered Establishments with PDI ]
Advisory Committee Gastroenterology
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 changing the labeling of the lixelle® ß2-microgliblin apheresis column regarding the conditions of use to allow a blood flow rate (qb) of up to 450 ml/min, which is currently set at 250 ml/min.
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