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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nameapheresis for focal glomerulosclerosis in adult and pediatric patients
Generic Nameapheresis for focal glomerulosclerosis in adult and pediatric patients
546 fifth ave., 21st floor
new york, NY 10036
HDE NumberH120005
Date Received09/04/2012
Decision Date10/10/2013
Product Code
PBN[ Registered Establishments with PBN ]
Docket Number 13M-1322
Notice Date 10/30/2013
Advisory Committee Gastroenterology
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the kaneka liposorber® la-15 system. This device is indicated for use in the treatment of pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis, when 1) standard treatment options, including corticosteroid and/or calcineurin inhibitors treatments,are unsuccessful or not well tolerated and the patient has a gfr 60 > ml/min/ 1. 73m2; or 2) the patient is post renal transplantation.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S009 S010 
S011 S012 S013 S014 S015 S016 S017 S018 S019 
S020 S021