PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody

FDA Premarket Approval P990081 S045

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

DevicePATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody
Generic NameSystem, Test, Her-2/neu, Ihc
ApplicantVENTANA MEDICAL SYSTEMS, INC.1910 E. Innovation Park Dr.tucson, AZ 85755 PMA NumberP990081 Supplement NumberS045 Date Received01/28/2022 Decision Date06/10/2022 Product Code MVC  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
PMAP990081
SupplementS045
Product CodeMVC 
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 Dr.
tucson, AZ 85755 PMA NumberP990081 Supplement NumberS045 Date Received01/28/2022 Decision Date06/10/2022 Product Code MVC  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
P990081Original Filing
S045 2022-01-28 135 Review Track For 30-day Notice
S044 2021-02-22 Real-time Process
S043 2020-08-26 Real-time Process
S042 2020-01-13 Real-time Process
S041 2019-08-22 Real-time Process
S040 2019-04-09 30-day Notice
S039 2019-02-13 Normal 180 Day Track
S038 2018-06-18 Real-time Process
S037
S036
S035 2016-11-15 Normal 180 Day Track
S034 2015-12-10 135 Review Track For 30-day Notice
S033 2015-08-26 30-day Notice
S032 2015-08-14 30-day Notice
S031 2014-10-27 30-day Notice
S030 2014-06-16 135 Review Track For 30-day Notice
S029 2014-02-14 Normal 180 Day Track
S028 2014-02-06 Real-time Process
S027 2014-01-22 Real-time Process
S026 2014-01-06 30-day Notice
S025 2013-12-27 30-day Notice
S024 2013-11-12 30-day Notice
S023 2013-10-28 30-day Notice
S022 2013-08-30 30-day Notice
S021 2013-07-30 30-day Notice
S020 2013-05-07 135 Review Track For 30-day Notice
S019 2013-05-06 Real-time Process
S018 2013-04-17 30-day Notice
S017 2013-03-12 Real-time Process
S016 2013-03-04 30-day Notice
S015 2013-01-14 Real-time Process
S014 2012-08-31 Real-time Process
S013 2012-07-27 30-day Notice
S012 2012-07-25 Real-time Process
S011 2011-05-23 Normal 180 Day Track
S010 2011-01-03 Normal 180 Day Track
S009
S008 2010-10-21 Special (immediate Track)
S007 2007-11-19 30-day Notice
S006 2007-06-27 30-day Notice
S005 2007-03-02 Special (immediate Track)
S004 2006-08-28 30-day Notice
S003 2006-05-04 Normal 180 Day Track
S002 2005-09-06 Real-time Process
S001 2002-08-20 Normal 180 Day Track

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