- Device
- PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P990081
- Supplement
- S060
- Product code
- MVC
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Decision date
- 2026-08-25
- Decision code
- APPR
- Date received
- 2026-03-25
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody as a companion diagnostic (CDx) for identifying patients with gastroesophageal adenocarcinoma (gastric, gastroesophageal junction, and esophageal adenocarcinoma) who may be eligible for treatment with ZIIHERA (zanidatamab).