|
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 |
|
HDE Number | H170002 |
Supplement Number | S003 |
Date Received | 03/20/2020 |
Decision Date | 04/17/2020 |
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 Approval for the revised protocol for the post-approval study (pas) protocol. |