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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 | S017 |
Date Received | 12/17/2021 |
Decision Date | 01/14/2022 |
Product Code | |
Advisory Committee |
Gastroenterology |
Supplement Type | special (immediate track) |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for modification to the labeling (within the instructions for use and operators manual) for the liposorber la-15 system. |