HDE supplement
H970004 S011: EXCORIM IMMUNOADSORPTION SYSTEM
FDA HDE supplement · normal 75 day track · FRESENIUS MEDICAL CARE
Key facts
| Original HDE | H970004 |
|---|---|
| Supplement number | S011 |
| Supplement type | normal 75 day track |
| Reason for the supplement | process change - manufacturer/sterilizer/packager/supplier |
| Trade name | EXCORIM IMMUNOADSORPTION SYSTEM |
| Generic name | Columns, immunoadsorption in extracorporeal systems |
| Applicant | FRESENIUS MEDICAL CARE |
| Product code | LQQ |
| Received date | May 2, 2006 |
| Decision date | Oct 3, 2006 |
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: