VENTANA HER2 Dual ISH DNA Probe Cocktail

FDA Premarket Approval P190031 S001

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

Replacement of dispenser molds used in the injection molding process for six (6) dispenser parts

DeviceVENTANA HER2 Dual ISH DNA Probe Cocktail
Generic NameChromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/neu Gene, Breast Cancer
ApplicantVentana Medical Systems, Inc.
Date Received2020-08-26
Decision Date2020-11-13
PMAP190031
SupplementS001
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
S001 2020-08-26 Real-time Process

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.