VENTANA PD-Ll (SP142) Assay

FDA Premarket Approval P160002 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 PD-Ll (SP142) Assay
Generic NameImmunohistochemistry Assay, Antibody, Programmed Death-ligand 1
ApplicantVENTANA MEDICAL SYSTEMS, INC.1910 East Innovation Park Dr.tucson, AZ 85755 PMA NumberP160002 Supplement NumberS017 Date Received02/16/2022 Decision Date07/21/2022 Product Code PLS  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
PMAP160002
SupplementS017
Product CodePLS 
Advisory CommitteePathology
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination ProductNo
Applicant AddressVENTANA MEDICAL SYSTEMS, INC.
1910 East Innovation Park Dr.
tucson, AZ 85755 PMA NumberP160002 Supplement NumberS017 Date Received02/16/2022 Decision Date07/21/2022 Product Code PLS  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
P160002Original 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 2021-09-07 Special (immediate Track)
S014 2021-02-22 Real-time Process
S013 2020-08-26 Real-time Process
S012 2020-01-21 Normal 180 Day Track
S011 2020-01-13 Real-time Process
S010 2019-08-22 Real-time Process
S009 2018-09-14 Panel Track
S008
S007 2018-06-18 Real-time Process
S006 2018-06-14 Normal 180 Day Track
S005
S004
S003 2017-07-17 30-day Notice
S002 2017-03-16 Normal 180 Day Track No User Fee
S001 2016-09-01 Normal 180 Day Track No User Fee

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