HDE supplement
H170002 S005: LIPOSORBER LA-15 System
FDA HDE supplement · normal 75 day track · Kaneka Pharma America LLC
Key facts
| Original HDE | H170002 |
|---|---|
| Supplement number | S005 |
| Supplement type | normal 75 day track |
| 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 | Feb 12, 2021 |
| Decision date | Aug 6, 2021 |
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: