PMA
P830063: GAMBRO FIBER PLASMAFILTER
FDA PMA · Separator for therapeutic purposes, membrane automated blood cell/plasma · Vantive US Healthcare, LLC
Key facts
| PMA number | P830063 |
|---|---|
| Trade name | GAMBRO FIBER PLASMAFILTER |
| Generic name | Separator for therapeutic purposes, membrane automated blood cell/plasma |
| Applicant | Vantive US Healthcare, LLC |
| Owner/operator | BAXTER HEALTHCARE CORPORATION |
| Product code | MDP |
| Approval date | May 27, 1986 |
| Docket number | 86M-0250 |
| Notice date | Jul 7, 1986 |
| Establishment registration | 1417572 |
| FEI number | 1417572 |
At a glance
- 10–99 Supplements
- Jul 15, 2026 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- No Withdrawn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: