# Siemens Healthcare Diagnostics, Inc.: PMA approval for Atellica IM free PSA II (fPSAII)

**Score:** 55/100

| Field | Value |
|---|---|
| Sponsor | Siemens Healthcare Diagnostics, Inc. |
| Product | Atellica IM free PSA II (fPSAII) |
| Generic / ingredient | Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions |
| Approval | PMA original approval (new class III device) |
| Application | P250026 |
| Decided | 2026-05-11 |
| Panel / class | Immunology |
| Sponsor location | Tarrytown, NY |

## Why this score
- A new product launch.

Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250026). Last refreshed: 2026-11-04T06:06:18.796Z.
From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.