|
Device | VENTANA PD-Ll (SP142) Assay |
Generic Name | Immunohistochemistry assay, antibody, programmed death-ligand 1 |
Applicant | VENTANA MEDICAL SYSTEMS, INC. 1910 EAST INNOVATION PARK DR. TUCSON, AZ 85755 |
PMA Number | P160002 |
Supplement Number | S023 |
Date Received | 10/30/2023 |
Decision Date | 01/26/2024 |
Product Code |
PLS |
Advisory Committee |
Pathology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement approval for a change in expiry dating (extension to the stability from 12 months to 18 months) for Hematoxylin (PN 760-2021) and Hematoxylin II (PN 790-2208). |