PMA P990081S059

Device: PATHWAY anti- HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody
Applicant: Ventana Medical Systems, Inc.
PMA number: P990081
Supplement: S059
Product code: MVC
Decision date: 2025-12-15
Classification: Pathology
Generic name: SYSTEM, TEST, HER-2/NEU, IHC
Approval order statement: This 180-day supplement is to expand labeling of the PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody assay for use as a companion diagnostic to identify patients with HER2-positive, advanced or metastatic breast cancer who may be eligible for treatment with ENHERTU (fam-trastuzumab deruxtecan-nxki) in combination with PERJETA (pertuzumab) as first-line treatment.

Current openFDA PMA Record#

Device: PATHWAY anti- HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody
Applicant: Ventana Medical Systems, Inc.
PMA number: P990081
Supplement: S059
Product code: MVC
Generic name: SYSTEM, TEST, HER-2/NEU, IHC
Decision date: 2025-12-15
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: This 180-day supplement is to expand labeling of the PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody assay for use as a companion diagnostic to identify patients with HER2-positive, advanced or metastatic breast cancer who may be eligible for treatment with ENHERTU (fam-trastuzumab deruxtecan-nxki) in combination with PERJETA (pertuzumab) as first-line treatment.