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Device | VENTANA PD-L1 (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 | S015 |
Date Received | 09/07/2021 |
Decision Date | 09/28/2021 |
Product Code |
PLS |
Advisory Committee |
Pathology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approved for removal of the triple negative breast cancer (TNBC) indication from the device intended use statement and labeling. |