- Device
- VENTANA PD-L1 (SP142) Assay
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P160002
- Supplement
- S020
- Product code
- PLS
- Generic name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- Decision date
- 2023-02-07
- Decision code
- APPR
- Date received
- 2023-01-13
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approved for removal of Urothelial Carcinoma (UC) indication from the device intended use statement and labeling.