PMA P160002S021
- Device
- VENTANA PD-Ll (SP142) Assay
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P160002
- Supplement
- S021
- Product code
- PLS
- Decision date
- 2023-08-29
- Classification
- Pathology
- Generic name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- Approval order statement
- Addition of two contract manufacturers as approved suppliers of parts/components.
Current openFDA PMA Record#
- Device
- VENTANA PD-Ll (SP142) Assay
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P160002
- Supplement
- S021
- Product code
- PLS
- Generic name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- Decision date
- 2023-08-29
- Decision code
- OK30
- Date received
- 2023-08-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of two contract manufacturers as approved suppliers of parts/components.