FDA.reportPublic FDA data

PMA P150013S027

Device
PD-L1 IHC 22C3 pharmDx
Applicant
Agilent Technologies, Inc.
PMA number
P150013
Supplement
S027
Product code
PLS
Decision date
2023-11-07
Classification
Pathology
Generic name
Immunohistochemistry assay, antibody, programmed death-ligand 1
Approval order statement
Approval for an expansion of the current PD-L1 IHC 22C3 pharmDX indication to include a companion diagnostic (CDx) indication to use as an aid in identifying gastric or gastroesophageal junction (GEJ) adenocarcinoma patients for treatment with KEYTRUDA® (pembrolizumab).

Current openFDA PMA Record#

Device
PD-L1 IHC 22C3 pharmDx
Applicant
Agilent Technologies, Inc.
PMA number
P150013
Supplement
S027
Product code
PLS
Generic name
Immunohistochemistry assay, antibody, programmed death-ligand 1
Decision date
2023-11-07
Decision code
APPR
Date received
2023-09-20
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for an expansion of the current PD-L1 IHC 22C3 pharmDX indication to include a companion diagnostic (CDx) indication to use as an aid in identifying gastric or gastroesophageal junction (GEJ) adenocarcinoma patients for treatment with KEYTRUDA® (pembrolizumab).