PD-L1 IHC 28-8 pharmDx

FDA Premarket Approval P150025 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

DevicePD-L1 IHC 28-8 pharmDx
Generic NameImmunohistochemistry Assay, Antibody, Programmed Death-ligand 1
ApplicantAgilent Technologies, Inc.5301 Stevens Creek Blvdsanta Clara, CA 95051 PMA NumberP150025 Supplement NumberS015 Date Received06/17/2022 Decision Date07/22/2022 Product Code PLS  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-06-17
Decision Date2022-07-22
PMAP150025
SupplementS015
Product CodePLS 
Advisory CommitteePathology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressAgilent Technologies, Inc.
5301 Stevens Creek Blvd
santa Clara, CA 95051 PMA NumberP150025 Supplement NumberS015 Date Received06/17/2022 Decision Date07/22/2022 Product Code PLS  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
Update Of Manufacturing Documents Relating To Post-QC Testing

Supplemental Filings

Supplement NumberDateSupplement Type
P150025Original Filing
S015 2022-06-17 30-day Notice
S014 2021-07-12 Normal 180 Day Track
S013 2019-12-16 Panel Track
S012
S011 2019-02-15 30-day Notice
S010 2018-12-21 30-day Notice
S009 2018-03-12 30-day Notice
S008 2017-12-26 30-day Notice
S007
S006 2017-04-17 30-day Notice
S005 2016-12-29 Normal 180 Day Track No User Fee
S004 2016-12-27 Real-time Process
S003 2016-12-22 Panel Track
S002 2016-08-19 Real-time Process
S001 2016-07-07 Real-time Process

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