VENTANA HER2 Dual ISI-I DNA Probe Cocktail

FDA Premarket Approval P190031 S002

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for the dispenser resin replacement used in the injection molding process for six (6) dispenser parts.

• Device: VENTANA HER2 Dual ISI-I DNA Probe Cocktail
• Generic Name: Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/neu Gene, Breast Cancer
• Applicant: Ventana Medical Systems, Inc.
• Date Received: 2021-02-22
• Decision Date: 2021-05-20
• PMA: P190031
• Supplement: S002
• Product Code: NYQ
• Advisory Committee: Pathology
• Supplement Type: Real-time Process
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: No
• Applicant Address: Ventana Medical Systems, Inc. 1910 E. Innovation Park Drive tucson, AZ 85755

Supplemental Filings

Supplement Number	Date	Supplement Type
P190031		Original Filing
S005	2022-07-12	30-day Notice
S004	2022-02-16	Special (immediate Track)
S003	2022-01-28	135 Review Track For 30-day Notice
S002	2021-02-22	Real-time Process
S001	2020-08-26	Real-time Process

NIH GUDID Devices

Device ID	PMA	Supp
07613336158432	P190031	000