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) CDx Assay |
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 | S010 |
Date Received | 11/09/2018 |
Decision Date | 12/07/2018 |
Product Code |
PKW |
Advisory Committee |
Pathology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Change to purification technology for one of the assay components and improvement in incoming quality control. |
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