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-C-KIT (9.7) REBBIT MONOCLONAL PRIMARY ANTIBODY |
Generic Name | Immunohistochemistry antibody assay, c-kit |
Regulation Number | 864.1860 |
Applicant | VENTANA MEDICAL SYSTEMS, INC. 1910 E. Innovation Park Dr. Tucson, AZ 85755 |
PMA Number | P020055 |
Supplement Number | S003 |
Date Received | 06/26/2012 |
Decision Date | 07/24/2012 |
Product Code |
NKF |
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 PART OF THE DEVICE. |
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