PMA
P990055: BAYER IMMUNO 1 COMPLEXED PSA ASSAY
FDA PMA · ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA) · Siemens Healthcare Diagnostics
Key facts
| PMA number | P990055 |
|---|---|
| Trade name | BAYER IMMUNO 1 COMPLEXED PSA ASSAY |
| Generic name | ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA) |
| Applicant | Siemens Healthcare Diagnostics |
| Owner/operator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Product code | NAF |
| Approval date | Sep 8, 2000 |
| Docket number | 00M-1524 |
| Notice date | Sep 26, 2000 |
| Establishment registration | 1219913 |
| FEI number | 1219913 |
At a glance
- 10–99 Supplements
- Jul 16, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: