- Device
- VENTANA PD-L1(SP142) Assay
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P160002
- Supplement
- S016
- Product code
- PLS
- Generic name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- Decision date
- 2022-06-10
- Decision code
- APPR
- Date received
- 2022-01-28
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the addition of two new contract manufacturers as approved suppliers for component parts.