PMA
P950021: ADVIA CENTAUR & ADVIA CENTAUR CP PSA IMMUNOASSAY
FDA PMA · Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions · Siemens Healthcare Diagnostics
Key facts
| PMA number | P950021 |
|---|---|
| Trade name | ADVIA CENTAUR & ADVIA CENTAUR CP PSA IMMUNOASSAY |
| Generic name | Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions |
| Applicant | Siemens Healthcare Diagnostics |
| Owner/operator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Product code | MTG |
| Approval date | Dec 22, 1995 |
| Docket number | 96M-0200 |
| Notice date | Jul 15, 1996 |
| Establishment registration | 1219913 |
| FEI number | 1219913 |
At a glance
- 10–99 Supplements
- Jul 16, 2025 Latest supplement decision
- No Withdrawn
- No 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: