PMA
P830010: CURESIS PLASMA SEPARATOR
FDA PMA · Separator, automated, blood cell and plasma, therapeutic · Organon Teknika Corp.
Key facts
| PMA number | P830010 |
|---|---|
| Trade name | CURESIS PLASMA SEPARATOR |
| Generic name | Separator, automated, blood cell and plasma, therapeutic |
| Applicant | Organon Teknika Corp. |
| Owner/operator | Organon LLC |
| Product code | LKN |
| Approval date | Sep 19, 1984 |
| Docket number | 84M-0338 |
| Notice date | Nov 9, 1984 |
| Establishment registration | 3017425145 |
| FEI number | 3017425145 |
At a glance
- 1–9 Supplements
- Dec 6, 1985 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness 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 PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: