PMA
P240021: Atellica IM Total PSA II (tPSAII)
FDA PMA · Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer · Siemens Healthcare Diagnostics, Inc.
Key facts
| PMA number | P240021 |
|---|---|
| Trade name | Atellica IM Total PSA II (tPSAII) |
| Generic name | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer |
| Applicant | Siemens Healthcare Diagnostics, Inc. |
| Owner/operator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Product code | MTF |
| Approval date | Dec 3, 2025 |
| Docket number | FDA-7025 |
| Notice date | Dec 12, 2025 |
| Establishment registration | 2432235 |
| FEI number | 2432235 |
At a glance
- 1–9 Supplements
- Aug 26, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: