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 | PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody |
Generic Name | system, test, her-2/neu, ihc |
Applicant |
VENTANA MEDICAL SYSTEMS, INC. |
1910 e. innovation park dr. |
tucson, AZ 85755 |
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PMA Number | P990081 |
Supplement Number | S035 |
Date Received | 11/15/2016 |
Decision Date | 03/13/2017 |
Product Code |
MVC
|
Advisory Committee |
Pathology |
Supplement Type | normal 180 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product |
No
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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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