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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 NumberS010
Date Received03/01/2018
Decision Date03/26/2018
Product Code
PBN[ Registered Establishments with PBN ]
Advisory Committee Gastroenterology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Replacement of the annealing oven used in the manufacturing process of the hollow fibers for the sulflux® kp-05 device.
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