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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 NumberS023
Date Received07/26/2024
Decision Date03/05/2025
Product Code
PBN[ Registered Establishments with PBN ]
Advisory Committee Gastroenterology
Supplement Typenormal 75 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
The center for devices and radiological health (cdrh) of the food and drug administration (fda) has completed its review of the above referenced premarket approval application (pma) 180-day supplement(s)/75-day humanitarian device exemption (hde) supplement(s), which requested approval for packaging material (the shape of the cap, removing one material (styrene elastomer) from the cap, and the welding of the cap to the device), labeling, and a new sterilization site at kaneka corporation tomatoh plant tomakomai, hokkaido, 059-1362 japan.
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