|
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 |
|
HDE Number | H120005 |
Supplement Number | S021 |
Date Received | 01/30/2023 |
Decision Date | 03/01/2023 |
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 in quality control testing for the liposorber la-15 system regarding a change of gas chromatograph (gc) equipment for measurement of residual propanol. |