PMA P160002S007
- Device
- VENTANA PD-L1(SP142) Assay
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P160002
- Supplement
- S007
- Product code
- PLS
- Decision date
- 2018-09-13
- Classification
- Immunohistochemistry Assay, Antibody, Programmed Death-ligand 1
- Generic name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- Approval order statement
- Approval for implementing a BenchMark Scanners software supplement for Ventana Systems Software (VSS) 12.3 on the BenchMark ULTRA Instrument.
Current openFDA PMA Record#
- Device
- VENTANA PD-L1(SP142) Assay
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P160002
- Supplement
- S007
- Product code
- PLS
- Generic name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- Decision date
- 2018-09-13
- Decision code
- APPR
- Date received
- 2018-06-18
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for implementing a BenchMark Scanners software supplement for Ventana Systems Software (VSS) 12.3 on the BenchMark ULTRA Instrument.