FDA.reportPublic FDA data

PMA P150013S020

Device
PD-L1 IHC 22C3 pharmDX
Applicant
Agilent Technologies, Inc.
PMA number
P150013
Supplement
S020
Product code
PLS
Decision date
2020-11-13
Generic name
Immunohistochemistry assay, antibody, programmed death-ligand 1
Approval order statement
Approval for the PD-L1 IHC 22C3 pharmDX for expanding the indications to include detection of PD-L1 protein in patients with triple-negative breast cancer (TNBC) for treatment with KEYTRUDA.

Current openFDA PMA Record#

Device
PD-L1 IHC 22C3 pharmDX
Applicant
Agilent Technologies, Inc.
PMA number
P150013
Supplement
S020
Product code
PLS
Generic name
Immunohistochemistry assay, antibody, programmed death-ligand 1
Decision date
2020-11-13
Decision code
APPR
Date received
2020-06-29
Supplement type
Panel Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for the PD-L1 IHC 22C3 pharmDX for expanding the indications to include detection of PD-L1 protein in patients with triple-negative breast cancer (TNBC) for treatment with KEYTRUDA.