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-Ll (SP263) Assay |
Generic Name | Immunohistochemistry assay, antibody, programmed death-ligand 1 |
Applicant | Ventana Medical Systems, Inc. 1910 E. Innovation Park Dr. Tucson, AZ 85755 |
PMA Number | P160046 |
Supplement Number | S016 |
Date Received | 08/01/2023 |
Decision Date | 08/29/2023 |
Product Code |
PLS |
Advisory Committee |
Pathology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Addition of two contract manufacturers as approved suppliers of parts/components. |
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