VENTANA ALK (D5F3) CDx Assay

FDA Premarket Approval P140025 S017

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

DeviceVENTANA ALK (D5F3) CDx Assay
Generic NameImmunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
ApplicantVENTANA MEDICAL SYSTEMS, INC.1910 East Innovation Park Dr.tucson, AZ 85755 PMA NumberP140025 Supplement NumberS017 Date Received02/16/2022 Decision Date07/21/2022 Product Code PKW  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
PMAP140025
SupplementS017
Product CodePKW 
Advisory CommitteePathology
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination ProductYes
Applicant AddressVENTANA MEDICAL SYSTEMS, INC.
1910 East Innovation Park Dr.
tucson, AZ 85755 PMA NumberP140025 Supplement NumberS017 Date Received02/16/2022 Decision Date07/21/2022 Product Code PKW  Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductYes 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
P140025Original Filing
S018 2022-07-12 30-day Notice
S017 2022-02-16 Special (immediate Track)
S016 2022-01-28 135 Review Track For 30-day Notice
S015 2021-02-22 Real-time Process
S014 2020-11-16 Normal 180 Day Track
S013 2020-08-26 Real-time Process
S012 2020-01-13 Real-time Process
S011 2019-08-22 Real-time Process
S010 2018-11-09 30-day Notice
S009 2018-06-18 Real-time Process
S008
S007 2017-07-17 30-day Notice
S006 2017-06-07 Normal 180 Day Track
S005 2016-12-28 Normal 180 Day Track
S004 2016-11-15 Normal 180 Day Track
S003 2016-03-22 Normal 180 Day Track
S002 2015-12-10 135 Review Track For 30-day Notice
S001 2015-08-26 30-day Notice

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