VENTANA PD-L1(SP142) Assay

FDA Premarket Approval P160002 S016

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-L1(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 NumberS016 Date Received01/28/2022 Decision Date06/10/2022 Product Code PLS  Advisory Committee Pathology Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-01-28
Decision Date2022-06-10
PMAP160002
SupplementS016
Product CodePLS 
Advisory CommitteePathology
Supplement Type135 Review Track For 30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressVENTANA MEDICAL SYSTEMS, INC.
1910 East Innovation Park Dr.
tucson, AZ 85755 PMA NumberP160002 Supplement NumberS016 Date Received01/28/2022 Decision Date06/10/2022 Product Code PLS  Advisory Committee Pathology Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
addition Of Two New Contract Manufacturers As Approved Suppliers For Component Parts

Supplemental Filings

Supplement NumberDateSupplement Type
P160002Original Filing
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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