# Ventana Medical Systems, Inc.: PMA supplement approved for PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

**Score:** 30/100

| Field | Value |
|---|---|
| Sponsor | Ventana Medical Systems, Inc. |
| Product | PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody |
| Generic / ingredient | SYSTEM, TEST, HER-2/NEU, IHC |
| Approval | PMA supplement (device change) |
| Application | P990081 S058 |
| Decided | 2026-05-15 |
| Panel / class | Pathology |
| Sponsor location | Tucson, AZ |

## 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=P990081S058). 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.