# Siemens Healthcare Diagnostics, Inc.: PMA supplement approved for Atellica IM Total PSA II (tPSAII)

**Score:** 30/100

| Field | Value |
|---|---|
| Sponsor | Siemens Healthcare Diagnostics, Inc. |
| Product | Atellica IM Total PSA II (tPSAII) |
| Generic / ingredient | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer |
| Approval | PMA supplement (device change) |
| Application | P240021 S001 |
| Decided | 2026-08-26 |
| Panel / class | Immunology |
| Sponsor location | Tarrytown, NY |

## Why this score


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=P240021S001). Last refreshed: 2026-11-06T09:50:50.140Z.
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.