VENTANA HER2 Dual ISH DNA Probe Cocktail

FDA Premarket Approval P190031 S004

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 NumberS004 Date Received02/16/2022 Decision Date07/21/2022 Product Code NYQ  Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
Date Received2022-02-16
Decision Date2022-07-21
PMAP190031
SupplementS004
Product CodeNYQ 
Advisory CommitteePathology
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination ProductNo
Applicant AddressVentana Medical Systems, Inc.
1910 E. Innovation Park Drive
tucson, AZ 85755 PMA NumberP190031 Supplement NumberS004 Date Received02/16/2022 Decision Date07/21/2022 Product Code NYQ  Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement  
approval For (i) A Change In Expiry Dating From Hematoxylin And Hematoxylin II And (ii) Implementation Of A Revised Process For Creating Reference Slides Used In Surveillance And Stability Testing Of Hematoxylin And Hematoxylin II

Supplemental Filings

Supplement NumberDateSupplement Type
P190031Original 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 IDPMASupp
07613336158432 P190031 000

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