|
Trade Name | LPOSORBER® 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 |
|
HDE Number | H170002 |
Supplement Number | S011 |
Date Received | 09/22/2022 |
Decision Date | 12/05/2022 |
Product Code | |
Advisory Committee |
Gastroenterology |
Supplement Type | normal 75 day track |
Supplement Reason | postapproval study protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Xxx. |