INFORM HER2 Dual ISH DNA Probe Cocktail

FDA Premarket Approval P100027 S038

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
ApplicantVENTANA MEDICAL SYSTEMS, INC.1910 E. Innovation Park Dr.tucson, AZ 85755 PMA NumberP100027 Supplement NumberS038 Date Received10/14/2022 Decision Date11/10/2022 Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-10-14
Decision Date2022-11-10
PMAP100027
SupplementS038
Advisory CommitteePathology
Supplement Type30-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 NumberS038 Date Received10/14/2022 Decision Date11/10/2022 Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement  
For Changes To A Manufacturing Process.

Supplemental Filings

Supplement NumberDateSupplement Type
P100027Original Filing
S038 2022-10-14 30-day Notice
S037 2022-07-12 30-day Notice
S036 2022-02-16 Special (immediate Track)
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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