PMA
P250026: Atellica IM free PSA II (fPSAII)
FDA PMA · Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions · Siemens Healthcare Diagnostics, Inc.
Key facts
| PMA number | P250026 |
|---|---|
| Trade name | Atellica IM free PSA II (fPSAII) |
| Generic name | Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions |
| Applicant | Siemens Healthcare Diagnostics, Inc. |
| Product code | MTG |
| Approval date | May 11, 2026 |
| Docket number | 26M-5545 |
| Notice date | May 11, 2026 |
At a glance
- None Supplements
- May 11, 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- No Withdrawn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: