VENTANA HER2 Dual ISH DNA Probe Cocktail

FDA Premarket Approval P190031 S003

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

DeviceVENTANA HER2 Dual ISH DNA Probe Cocktail
Generic NameChromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/neu Gene, Breast Cancer
ApplicantVentana Medical Systems, Inc.1910 E. Innovation Park Drivetucson, AZ 85755 PMA NumberP190031 Supplement NumberS003 Date Received01/28/2022 Decision Date06/10/2022 Product Code NYQ  Advisory Committee Pathology Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-01-28
Decision Date2022-06-10
PMAP190031
SupplementS003
Product CodeNYQ 
Advisory CommitteePathology
Supplement Type135 Review Track For 30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressVentana Medical Systems, Inc.
1910 E. Innovation Park Drive
tucson, AZ 85755 PMA NumberP190031 Supplement NumberS003 Date Received01/28/2022 Decision Date06/10/2022 Product Code NYQ  Advisory Committee Pathology Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
addition Of Two New Contract Manufacturers As Approved Suppliers For Component Parts

Supplemental Filings

Supplement NumberDateSupplement Type
P190031Original Filing
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 IDPMASupp
07613336158432 P190031 000

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.