PD-L1 IHC 22C3 pharmDx

FDA Premarket Approval P150013 S025

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

DevicePD-L1 IHC 22C3 pharmDx
Generic NameImmunohistochemistry Assay, Antibody, Programmed Death-ligand 1
ApplicantAgilent Technologies, Inc.5301 Stevens Creek Blvdsanta Clara, CA 95051 PMA NumberP150013 Supplement NumberS025 Date Received08/08/2022 Decision Date11/03/2022 Product Code PLS  Advisory Committee Pathology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
Date Received2022-08-08
Decision Date2022-11-03
PMAP150013
SupplementS025
Product CodePLS 
Advisory CommitteePathology
Supplement TypeReal-time Process
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination ProductNo
Applicant AddressAgilent Technologies, Inc.
5301 Stevens Creek Blvd
santa Clara, CA 95051 PMA NumberP150013 Supplement NumberS025 Date Received08/08/2022 Decision Date11/03/2022 Product Code PLS  Advisory Committee Pathology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement  
The Cut Section Storage Recommendation For Cervical Cancer Tissue Will Be Updated, To Change The Recommended Maximum Duration Of Storage At 2-8ºC From 5 Months To 2 Months.

Supplemental Filings

Supplement NumberDateSupplement Type
P150013Original Filing
S025 2022-08-08 Real-time Process
S024 2022-01-31 Special (immediate Track)
S023 2021-11-17 Special (immediate Track)
S022
S021 2020-08-31 Normal 180 Day Track
S020 2020-06-29 Panel Track
S019 2020-02-06 Normal 180 Day Track No User Fee
S018 2019-09-05 Normal 180 Day Track No User Fee
S017 2019-06-14 Normal 180 Day Track
S016 2019-02-25 Panel Track
S015 2019-02-15 30-day Notice
S014
S013 2018-12-21 30-day Notice
S012
S011 2018-06-25 Panel Track
S010 2018-03-12 30-day Notice
S009 2018-01-29 Panel Track
S008 2017-12-26 30-day Notice
S007 2017-09-21 Normal 180 Day Track No User Fee
S006 2017-04-19 Panel Track
S005 2017-04-17 30-day Notice
S004 2016-12-27 Real-time Process
S003 2016-08-19 Real-time Process
S002 2016-06-28 Real-time Process
S001 2015-12-31 Panel Track

NIH GUDID Devices

Device IDPMASupp
05700571107300 P150013 000
05700573003563 P150013 000
05700571112755 P150013 000

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.