PATHWAY Anti-c-KIT (9.7) Primary Antibody

FDA Premarket Approval P020055 S023

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

Replacement of dispenser molds used in the injection molding process for six (6) dispenser parts

DevicePATHWAY Anti-c-KIT (9.7) Primary Antibody
Generic NameImmunohistochemistry Antibody Assay, C-kit
ApplicantVENTANA MEDICAL SYSTEMS, INC.
Date Received2020-08-26
Decision Date2020-11-13
PMAP020055
SupplementS023
Product CodeNKF 
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
P020055Original Filing
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

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.