PMA supplement
BP850001 S030: Autopheresis-C Plasmapheresis System
FDA PMA supplement · Normal 180 Day Track · Baxter Healthcare Corporation
Key facts
| Original PMA | BP850001 |
|---|---|
| Supplement number | S030 |
| Supplement type | Normal 180 Day Track |
| Trade name | Autopheresis-C Plasmapheresis System |
| Generic name | Automated blood cell separator -filtration |
| Applicant | Baxter Healthcare Corporation |
| Product code | GKT |
| Received date | May 10, 1995 |
| Decision date | Jun 28, 1995 |
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: