HDE
H170002: LIPOSORBER LA-15 System
FDA Humanitarian Device Exemption · Kaneka Pharma America LLC
Key facts
| HDE number | H170002 |
|---|---|
| Trade name | LIPOSORBER LA-15 System |
| Generic name | Apheresis for focal glomerulosclerosis in adult and pediatric patients |
| Applicant | Kaneka Pharma America LLC |
| Owner/operator | KANEKA CORP. |
| Product code | PBN |
| Approval date | Mar 20, 2018 |
| Docket number | 18M-1215 |
| Notice date | Apr 11, 2018 |
| Establishment registration | 3031408734 |
| FEI number | 3031408734 |
At a glance
- 10–99 Supplements
- Aug 26, 2026 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- 1–9 UDI device identifiers (GUDID)
- 1–9 MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE approvals
A Humanitarian Device Exemption (HDE) authorizes devices intended to benefit patients with rare diseases or conditions affecting small populations in the United States.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: