HDE supplement
H170002 S008: LIPOSORBER LA-15 System
FDA HDE supplement · special (immediate track) · Kaneka Pharma America LLC
Key facts
| Original HDE | H170002 |
|---|---|
| Supplement number | S008 |
| 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: