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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 NumberS006
Date Received04/13/2017
Decision Date05/23/2017
Product Code
PBN[ Registered Establishments with PBN ]
Advisory Committee Gastroenterology
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for changes to the housing of adsorption column la-15 and connector parts of tubing system nk-m3r(u), plus components of the liposorber® la-15 system. The device, as modified, will be marketed under the trade name liposorber® la-15 system and 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 corticosteroids and/or calcineurin inhibitortreatments, are unsuccessful or not well tolerated and the patient’s glomerular filtrationrate (gfr) >= 60 ml/min/1. 73 m2 or; 2) the patient is post renal transplantation.
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