PMA P160046S015
- Device
- VENTANA PD-L1 (SP263) Assay
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P160046
- Supplement
- S015
- Decision date
- 2022-11-10
- Approval order statement
- Changes to a manufacturing process.
Current openFDA PMA Record#
- Device
- VENTANA PD-L1 (SP263) Assay
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P160046
- Supplement
- S015
- Decision date
- 2022-11-10
- Decision code
- OK30
- Date received
- 2022-10-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to a manufacturing process.