HDE supplement
H120005 S019: Liposorber LA-15 System
FDA HDE supplement · 30-day notice · KANEKA PHARMA AMERICA LLC
Key facts
| Original HDE | H120005 |
|---|---|
| Supplement number | S019 |
| Supplement type | 30-day notice |
| Reason for the supplement | process change - manufacturer/sterilizer/packager/supplier |
| Trade name | Liposorber LA-15 System |
| Generic name | Apheresis for focal glomerulosclerosis in adult and pediatric patients |
| Applicant | KANEKA PHARMA AMERICA LLC |
| Product code | PBN |
| Received date | May 31, 2022 |
| Decision date | Jun 30, 2022 |
At a glance
- No Approval order on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE supplements
An HDE supplement asks FDA to approve a change to a Humanitarian Use Device that already holds a humanitarian device exemption.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: