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 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 |
PMA Number | P990081 |
Supplement Number | S013 |
Date Received | 07/27/2012 |
Decision Date | 08/09/2012 |
Product Code |
MVC |
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 ADDITION OF A SUPPLIER OF RAW MATERIALS FOR THE IVIEW DETECTION KIT, WHICH IS PARTOF THE DEVICE. |
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