HDE supplement
H120005 S017: LIPOSORBER LA-15 System
FDA HDE supplement · special (immediate track) · KANEKA PHARMA AMERICA LLC
Key facts
| Original HDE | H120005 |
|---|---|
| Supplement number | S017 |
| Supplement type | special (immediate track) |
| Reason for the supplement | labeling change - indications/instructions/shelf life/tradename |
| 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 | Dec 17, 2021 |
| Decision date | Jan 14, 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: