PMA P160002S024
- Device
- VENTANA PD-L1(SP142) Assay
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P160002
- Supplement
- S024
- Product code
- PLS
- Decision date
- 2024-04-01
- Classification
- Pathology
- Generic name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- Approval order statement
- for addition of raw material evaluation method to ensure quality of the incoming reagents
Current openFDA PMA Record#
- Device
- VENTANA PD-L1(SP142) Assay
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P160002
- Supplement
- S024
- Product code
- PLS
- Generic name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- Decision date
- 2024-04-01
- Decision code
- OK30
- Date received
- 2024-03-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- for addition of raw material evaluation method to ensure quality of the incoming reagents