Inform HER2 Dual ISH DNA Probe Cocktail

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/neu Gene, Breast Cancer

FDA Premarket Approval P100027 S031

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 minor software and firmware updates for ventana system software on the benchmark ultra instruments.

DeviceInform HER2 Dual ISH DNA Probe Cocktail
Classification NameChromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/neu Gene, Breast Cancer
Generic NameChromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/neu Gene, Breast Cancer
ApplicantVENTANA MEDICAL SYSTEMS, INC.
Date Received2019-08-22
Decision Date2019-11-19
PMAP100027
SupplementS031
Product CodeNYQ
Advisory CommitteePathology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product Yes
Applicant Address VENTANA MEDICAL SYSTEMS, INC. 1910 E. Innovation Park Dr. tucson, AZ 85755

Supplemental Filings

Supplement NumberDateSupplement Type
P100027Original Filing
S031 2019-08-22 Real-time Process
S030 2019-02-13 Normal 180 Day Track
S029 2018-06-18 Real-time Process
S028
S027 2017-07-17 30-day Notice
S026 2016-11-15 Normal 180 Day Track
S025 2016-11-04 30-day Notice
S024 2015-12-10 135 Review Track For 30-day Notice
S023 2015-08-26 30-day Notice
S022 2015-08-14 30-day Notice
S021 2015-02-11 30-day Notice
S020 2014-10-27 30-day Notice
S019 2014-06-16 135 Review Track For 30-day Notice
S018 2014-05-01 Real-time Process
S017 2014-02-06 Real-time Process
S016 2014-01-22 Real-time Process
S015 2014-01-06 30-day Notice
S014 2013-12-27 30-day Notice
S013 2013-11-12 30-day Notice
S012 2013-10-28 30-day Notice
S011 2013-09-12 30-day Notice
S010 2013-05-07 30-day Notice
S009 2013-05-06 Real-time Process
S008 2013-04-17 30-day Notice
S007 2013-03-12 Real-time Process
S006 2013-03-04 30-day Notice
S005 2012-10-10 Normal 180 Day Track
S004 2012-09-26 Real-time Process
S003 2012-08-31 Real-time Process
S002 2011-09-19 Normal 180 Day Track
S001 2011-08-29 Real-time Process

© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.