PATHWAY Anti-c-KIT (9.7) Primary Antibody

FDA Premarket Approval P020055 S025

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-c-KIT (9.7) Primary Antibody
Generic NameImmunohistochemistry Antibody Assay, C-kit
ApplicantVENTANA MEDICAL SYSTEMS, INC.1910 E. Innovation Park Dr.tucson, AZ 85755 PMA NumberP020055 Supplement NumberS025 Date Received01/28/2022 Decision Date06/10/2022 Product Code NKF  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
PMAP020055
SupplementS025
Product CodeNKF 
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 NumberP020055 Supplement NumberS025 Date Received01/28/2022 Decision Date06/10/2022 Product Code NKF  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
P020055Original Filing
S025 2022-01-28 135 Review Track For 30-day Notice
S024 2021-02-22 Real-time Process
S023 2020-08-26 Real-time Process
S022 2020-01-13 Real-time Process
S021
S020 2017-07-17 30-day Notice
S019 2016-11-15 Normal 180 Day Track
S018 2015-12-10 135 Review Track For 30-day Notice
S017 2015-08-26 30-day Notice
S016 2014-10-27 30-day Notice
S015 2014-06-16 135 Review Track For 30-day Notice
S014 2014-02-06 Real-time Process
S013 2014-01-06 30-day Notice
S012 2013-11-12 30-day Notice
S011 2013-10-28 30-day Notice
S010 2013-10-11 Normal 180 Day Track
S009 2013-08-30 30-day Notice
S008 2013-05-06 Real-time Process
S007 2013-04-17 30-day Notice
S006 2013-03-04 30-day Notice
S005 2012-12-11 Real-time Process
S004 2012-08-31 Real-time Process
S003 2012-06-26 30-day Notice
S002 2011-05-23 Normal 180 Day Track
S001 2007-04-16 30-day Notice

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