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 | S034 |
Date Received | 12/10/2015 |
Decision Date | 04/13/2016 |
Product Code |
MVC
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Advisory Committee |
Pathology |
Supplement Type | 135 review track for 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product |
Yes
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Approval Order Statement
Approval for the following:1) Enlargement of a bulk formulation room at Ventana Medical Systems' Tucson, AZ facility; and 2) addition of two large volume tanks, along with supply plumbing, a clean in place (CIP) procedure, and new filler, as well as a new fill line. |
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