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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 avenue, 21st floor
new york, NY 10036
HDE NumberH170002
Supplement NumberS002
Date Received04/23/2019
Decision Date05/22/2019
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 
Layout change of the manufacturing site for the liposorber la-15 ldl adsorption column, a component of the liposorber la-15 system device.
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