VENTANA PD-Ll (SP263) Assay

FDA Premarket Approval P160046 S012

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 (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 NumberS012 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
PMAP160046
SupplementS012
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 E. Innovation Park Dr.
tucson, AZ 85755 PMA NumberP160046 Supplement NumberS012 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
P160046Original Filing
S014 2022-07-12 30-day Notice
S013
S012 2022-02-16 Special (immediate Track)
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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