PATHWAY Anti-c-KIT (9.7) Primary Antibody

FDA Premarket Approval P020055 S026

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 NumberS026 Date Received02/16/2022 Decision Date07/21/2022 Product Code NKF  Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
Date Received2022-02-16
Decision Date2022-07-21
PMAP020055
SupplementS026
Product CodeNKF 
Advisory CommitteePathology
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination ProductNo
Applicant AddressVENTANA MEDICAL SYSTEMS, INC.
1910 E. Innovation Park Dr.
tucson, AZ 85755 PMA NumberP020055 Supplement NumberS026 Date Received02/16/2022 Decision Date07/21/2022 Product Code NKF  Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement  
approval For (i) A Change In Expiry Dating From Hematoxylin And Hematoxylin II And (ii) Implementation Of A Revised Process For Creating Reference Slides Used In Surveillance And Stability Testing Of Hematoxylin And Hematoxylin II

Supplemental Filings

Supplement NumberDateSupplement Type
P020055Original Filing
S027 2022-07-12 30-day Notice
S026 2022-02-16 Special (immediate Track)
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

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.