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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 NumberS005
Date Received07/29/2016
Decision Date10/12/2016
Product Code
PBN[ Registered Establishments with PBN ]
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 
For modifications to the instructions for use and operator's manual for the liposorber® la-15 system for treatment of pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis (fsgs) and integration of the instructions for use for the liposorber® la-15 system for familial hypercholesterolemia and focal segmental glomerulosclerosis.
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