PMA P160046S012

Device: VENTANA PD-Ll (SP263) Assay
Applicant: Ventana Medical Systems, Inc.
PMA number: P160046
Supplement: S012
Product code: PLS
Decision date: 2022-07-21
Generic name: Immunohistochemistry assay, antibody, programmed death-ligand 1
Approval order statement: Approval for (i) a change in expiry dating from Hematoxylin and Hematoxylin II and (ii) implementation of a revised process for creating reference slides used in Surveillance and Stability testing of Hematoxylin and Hematoxylin II.

Current openFDA PMA Record#

Device: VENTANA PD-Ll (SP263) Assay
Applicant: Ventana Medical Systems, Inc.
PMA number: P160046
Supplement: S012
Product code: PLS
Generic name: Immunohistochemistry assay, antibody, programmed death-ligand 1
Decision date: 2022-07-21
Decision code: APPR
Date received: 2022-02-16
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for (i) a change in expiry dating from Hematoxylin and Hematoxylin II and (ii) implementation of a revised process for creating reference slides used in Surveillance and Stability testing of Hematoxylin and Hematoxylin II.