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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 avenue, 21st floor
new york, NY 10036
HDE NumberH170002
Supplement NumberS003
Date Received03/20/2020
Decision Date04/17/2020
Product Code
PBN[ Registered Establishments with PBN ]
Advisory Committee Gastroenterology
Supplement Typenormal 75 day track
Supplement Reason postapproval study protocol - ode/oir
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the revised protocol for the post-approval study (pas) protocol.
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