PMA P190031S014

Device: HER2 Dual ISH DNA Probe Cocktail
Applicant: Ventana Medical Systems, Inc.
PMA number: P190031
Supplement: S014
Product code: NYQ
Decision date: 2025-12-15
Classification: Pathology
Generic name: Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
Approval order statement: This 180-day supplement is to expand labeling of the HER2 Dual ISH DNA Probe Cocktail 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: HER2 Dual ISH DNA Probe Cocktail
Applicant: Ventana Medical Systems, Inc.
PMA number: P190031
Supplement: S014
Product code: NYQ
Generic name: Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
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 HER2 Dual ISH DNA Probe Cocktail 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.