|
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 | S019 |
Date Received | 05/31/2022 |
Decision Date | 06/30/2022 |
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 This submission requests for a change in the material supplier of the nk-m3r(ul) which is a component device of the liposorber la-15 system and one manufacturing process. The change is being made because the original supplier no longer produces the material. |