PMA
BP850001: Autopheresis-C Plasmapheresis System
FDA PMA · Automated blood cell separator -filtration · Baxter Healthcare Corporation
Key facts
| PMA number | BP850001 |
|---|---|
| Trade name | Autopheresis-C Plasmapheresis System |
| Generic name | Automated blood cell separator -filtration |
| Applicant | Baxter Healthcare Corporation |
| Owner/operator | BAXTER HEALTHCARE CORPORATION |
| Product code | GKT |
| Approval date | Mar 24, 1986 |
| Establishment registration | 1417572 |
| FEI number | 1417572 |
At a glance
- 10–99 Supplements
- Mar 2, 2001 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 1–9 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: