PMA
BP130076: INTERCEPT(R) Blood System for Plasma
FDA PMA · Preparation and storage of pathogen-reduced, blood components. · Cerus Corporation
Key facts
| PMA number | BP130076 |
|---|---|
| Trade name | INTERCEPT(R) Blood System for Plasma |
| Generic name | Preparation and storage of pathogen-reduced, blood components. |
| Applicant | Cerus Corporation |
| Owner/operator | Cerus Corporation |
| Product code | PJF |
| Approval date | Dec 16, 2014 |
| Establishment registration | 3003925919 |
| FEI number | 3003925919 |
At a glance
- 10–99 Supplements
- Jun 16, 2023 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- No Withdrawn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: