PMA P160046S006
- Device
- Ventana PD-Ll (SP263) Assay
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P160046
- Supplement
- S006
- Product code
- PLS
- Decision date
- 2019-11-19
- Classification
- Immunohistochemistry Assay, Antibody, Programmed Death-ligand 1
- Generic name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- Approval order statement
- Approval for minor software and firmware updates for Ventana System Software on the BenchMark ULTRA instruments.
Current openFDA PMA Record#
- Device
- Ventana PD-Ll (SP263) Assay
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P160046
- Supplement
- S006
- Product code
- PLS
- Generic name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- Decision date
- 2019-11-19
- Decision code
- APPR
- Date received
- 2019-08-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for minor software and firmware updates for Ventana System Software on the BenchMark ULTRA instruments.