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 (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 | S005 |
Date Received | 06/18/2018 |
Decision Date | 09/13/2018 |
Product Code |
PLS |
Advisory Committee |
Pathology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for implementing a BenchMark Scanners software supplement for Ventana Systems Software (VSS) 12.3 on the BenchMark ULTRA Instrument. |
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