INFORM HER2 Dual ISH DNA Probe Cocktail

FDA Premarket Approval P100027 S035

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

DeviceINFORM 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 Dr.tucson, AZ 85755 PMA NumberP100027 Supplement NumberS035 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
PMAP100027
SupplementS035
Product CodeNYQ 
Advisory CommitteePathology
Supplement Type135 Review Track For 30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductYes
Applicant AddressVENTANA MEDICAL SYSTEMS, INC.
1910 E. Innovation Park Dr.
tucson, AZ 85755 PMA NumberP100027 Supplement NumberS035 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 ProductYes Approval Order Statement  
addition Of Two New Contract Manufacturers As Approved Suppliers For Component Parts

Supplemental Filings

Supplement NumberDateSupplement Type
P100027Original Filing
S035 2022-01-28 135 Review Track For 30-day Notice
S034 2021-02-22 Real-time Process
S033 2020-08-26 Real-time Process
S032 2020-01-13 Real-time Process
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

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