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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.
 
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
Date Received06/16/2017
Decision Date03/20/2018
Product Code
PBN[ Registered Establishments with PBN ]
Docket Number 18M-1215
Notice Date 04/11/2018
Advisory Committee Gastroenterology
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the liposorber® la-15 system to expand the indication to include adult patients with nephrotic syndrome. The liposorber® la-15 is indicated for use in the treatment of adult and pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis, when 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 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 
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