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 ALK (D5F3) |
Generic Name | Immunohistochemistry assay, antibody, anaplastic lymphoma kinase |
Applicant | VENTANA MEDICAL SYSTEMS, INC. 1910 EAST INNOVATION PARK DR. TUCSON, AZ 85755 |
PMA Number | P140025 |
Supplement Number | S004 |
Date Received | 11/15/2016 |
Decision Date | 03/13/2017 |
Product Code |
PKW |
Advisory Committee |
Pathology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for software modification in the BenchMark XT from NexES to VSS 12.5 and associated hardware changes. |
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