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.

DeviceVENTANA HER2 Dual ISI-I DNA Probe Cocktail
Generic NameChromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/neu Gene, Breast Cancer
ApplicantVentana Medical Systems, Inc.
Date Received2021-02-22
Decision Date2021-05-20
PMAP190031
SupplementS002
Product CodeNYQ 
Advisory CommitteePathology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Ventana Medical Systems, Inc. 1910 E. Innovation Park Drive tucson, AZ 85755

Supplemental Filings

Supplement NumberDateSupplement Type
P190031Original Filing
S002 2021-02-22 Real-time Process
S001 2020-08-26 Real-time Process

NIH GUDID Devices

Device IDPMASupp
07613336158432 P190031 000

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