PMA
P000021: DIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGE
FDA PMA · PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS · Siemens Healthcare Diagnostics
Key facts
| PMA number | P000021 |
|---|---|
| Trade name | DIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGE |
| Generic name | PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS |
| Applicant | Siemens Healthcare Diagnostics |
| Owner/operator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Product code | LTJ |
| Approval date | Jul 5, 2001 |
| Docket number | 01M-0310 |
| Notice date | Jul 23, 2001 |
| 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- No Withdrawn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: