- Device
- PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P990081
- Supplement
- S058
- Product code
- MVC
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Decision date
- 2026-05-15
- Decision code
- APPR
- Date received
- 2025-08-15
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval to include the PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (PATHWAY anti-HER2 (4B5) antibody) as a companion diagnostic indication for the detection of HER2 antigen in patients with breast cancer who may benefit from treatment with ENHERTU® (fam-trastuzumab deruxtecan-nxki).