PMA P190031

Device: VENTANA HER2 Dual ISH DNA Probe Cocktail
Applicant: Ventana Medical Systems, Inc.
PMA number: P190031
Supplement: S005
Product code: NYQ
Decision date: 2026-08-25
Generic name: Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer
Approval order statement: Approval of VENTANA HER2 Dual ISH DNA Probe Cocktail to add the indication for use as a companion diagnostic (CDx) for identifying patients with gastroesophageal adenocarcinoma (GEA; gastric, gastroesophageal junction and esophageal adenocarcinoma) who many benefit from treatment with ZIIHERA (zanidatamab).

Current openFDA PMA Record#

Device: VENTANA HER2 Dual ISH DNA Probe Cocktail
Applicant: Ventana Medical Systems, Inc.
PMA number: P190031
Supplement: S016
Product code: NYQ
Generic name: Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer
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 of VENTANA HER2 Dual ISH DNA Probe Cocktail to add the indication for use as a companion diagnostic (CDx) for identifying patients with gastroesophageal adenocarcinoma (GEA; gastric, gastroesophageal junction and esophageal adenocarcinoma) who many benefit from treatment with ZIIHERA (zanidatamab).