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Trade Name | LIPOSORBER LA-15 System |
Classification Name | apheresis for focal glomerulosclerosis in adult and pediatric patients |
Generic Name | apheresis for focal glomerulosclerosis in adult and pediatric patients |
Applicant |
KANEKA PHARMA AMERICA LLC |
546 fifth ave., 21st floor |
new york, NY 10036 |
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HDE Number | H120005 |
Supplement Number | S005 |
Date Received | 07/29/2016 |
Decision Date | 10/12/2016 |
Product Code | |
Advisory Committee |
Gastroenterology |
Supplement Type | normal 75 day track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement For modifications to the instructions for use and operator's manual for the liposorber® la-15 system for treatment of pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis (fsgs) and integration of the instructions for use for the liposorber® la-15 system for familial hypercholesterolemia and focal segmental glomerulosclerosis. |