PMA
P020027: DIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION T/F PSA CALIBRATOR FOR DIMENSION RXL AND XPAND SYSTEMS
FDA PMA · Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions · Siemens Healthcare Diagnostics
Key facts
| PMA number | P020027 |
|---|---|
| Trade name | DIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION T/F PSA CALIBRATOR FOR DIMENSION RXL AND XPAND SYSTEMS |
| 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 | Jan 24, 2003 |
| Docket number | 03M-0046 |
| Notice date | Feb 5, 2003 |
| Establishment registration | 2517506 |
| FEI number | 2517506 |
At a glance
- 10–99 Supplements
- May 22, 2025 Latest supplement decision
- No Withdrawn
- Yes 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: