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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 | S011 |
Date Received | 03/29/2018 |
Decision Date | 04/12/2018 |
Product Code | |
Advisory Committee |
Gastroenterology |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Change to the bioburden recovery procedure of the sterilization process used for the sulflux® kp-05 device, a component of the liposorber® la-15 system. |