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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 NameLIPOSORBER LA-15 System
Classification Nameapheresis for focal glomerulosclerosis in adult and pediatric patients
Generic Nameapheresis for focal glomerulosclerosis in adult and pediatric patients
Applicant
KANEKA PHARMA AMERICA LLC
546 fifth ave., 21st floor
new york, NY 10036
HDE NumberH120005
Supplement NumberS014
Date Received02/12/2021
Decision Date08/06/2021
Product Code
PBN[ Registered Establishments with PBN ]
Advisory Committee Gastroenterology
Supplement Typenormal 75 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Requested addition of the gel bioburden reduction tank, used for washing the cellulose gel material, to the manufacturing procedure for the liposorber la-15 ldl adsorption column (la-15 column).
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