VENTANA PD-L1 (SP142) Assay

FDA Premarket Approval P160002 S015

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

Approved for removal of the triple negative breast cancer (tnbc) indication from the device intended use statement and labeling.

DeviceVENTANA PD-L1 (SP142) Assay
Generic NameImmunohistochemistry Assay, Antibody, Programmed Death-ligand 1
Date Received2021-09-07
Decision Date2021-09-28
Product CodePLS 
Advisory CommitteePathology
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address VENTANA MEDICAL SYSTEMS, INC. 1910 East Innovation Park Dr. tucson, AZ 85755

Supplemental Filings

Supplement NumberDateSupplement Type
P160002Original Filing
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
S007 2018-06-18 Real-time Process
S006 2018-06-14 Normal 180 Day Track
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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