PMA supplement
P830010 S001: CURESIS PLASMA SEPARATOR
FDA PMA supplement · Organon Teknika Corp.
Key facts
| Original PMA | P830010 |
|---|---|
| Supplement number | S001 |
| Trade name | CURESIS PLASMA SEPARATOR |
| Generic name | Separator for therapeutic purposes, membrane automated blood cell/plasma |
| Applicant | Organon Teknika Corp. |
| Product code | MDP |
| Received date | Nov 19, 1984 |
| Decision date | Feb 12, 1985 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: