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

FDA Premarket Approval P990081 S044

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 the dispenser resin replacement used in the injection molding process for six (6) dispenser parts.

DevicePATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody
Generic NameSystem, Test, Her-2/neu, Ihc
Date Received2021-02-22
Decision Date2021-05-20
Product CodeMVC 
Advisory CommitteePathology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address VENTANA MEDICAL SYSTEMS, INC. 1910 E. Innovation Park Dr. tucson, AZ 85755

Supplemental Filings

Supplement NumberDateSupplement Type
P990081Original Filing
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
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
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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