HDE
H970004: IMMUNOSORBA PROTEIN A COLUMN AND IMMUNOSORBA PROTEIN A SEPHAROSE COLUMN
FDA Humanitarian Device Exemption · FRESENIUS MEDICAL CARE
Key facts
| HDE number | H970004 |
|---|---|
| Trade name | IMMUNOSORBA PROTEIN A COLUMN AND IMMUNOSORBA PROTEIN A SEPHAROSE COLUMN |
| Generic name | Columns, immunoadsorption in extracorporeal systems |
| Applicant | FRESENIUS MEDICAL CARE |
| Owner/operator | FRESENIUS MEDICAL CARE |
| Product code | LQQ |
| Approval date | Apr 6, 1998 |
| Docket number | 98M-0435 |
| Establishment registration | 9611824 |
| FEI number | 3002806960 |
At a glance
- 10–99 Supplements
- Oct 3, 2006 Latest supplement decision
- No Summary of safety and probable benefit on file
- None UDI device identifiers (GUDID)
- None 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: