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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 avenue, 21st floor |
new york, NY 10036 |
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HDE Number | H170002 |
Supplement Number | S005 |
Date Received | 02/12/2021 |
Decision Date | 08/06/2021 |
Product Code | |
Advisory Committee |
Gastroenterology |
Supplement Type | normal 75 day track |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Requested addition of the gel bioburden reduction tank, used for washing the cellulose gel material, to the manufacturing procedure for the liposorber la-15 ldl adsorption column (la-15 column). |