VENTANA PD-L1 (SP263) Assay

FDA Premarket Approval P160046 S011

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 (SP263) Assay
Generic NameImmunohistochemistry Assay, Antibody, Programmed Death-ligand 1
ApplicantVentana Medical Systems, Inc.1910 E. Innovation Park Dr.tucson, AZ 85755 PMA NumberP160046 Supplement NumberS011 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
PMAP160046
SupplementS011
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 E. Innovation Park Dr.
tucson, AZ 85755 PMA NumberP160046 Supplement NumberS011 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
P160046Original Filing
S011 2022-01-28 135 Review Track For 30-day Notice
S010 2021-06-14 Panel Track
S009 2021-02-22 Real-time Process
S008 2020-08-26 Real-time Process
S007 2020-01-13 Real-time Process
S006 2019-08-22 Real-time Process
S005 2018-06-18 Real-time Process
S004 2018-04-03 Normal 180 Day Track No User Fee
S003
S002
S001 2017-07-17 30-day Notice

NIH GUDID Devices

Device IDPMASupp
04015630972784 P160046 000

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