Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | VENTANA PD-L1(SP142) CDX 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 | S001 |
Date Received | 09/01/2016 |
Decision Date | 12/21/2016 |
Product Code |
PLS |
Advisory Committee |
Pathology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the updated product labels and associated data. |
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