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) 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 | S002 |
Date Received | 05/23/2011 |
Decision Date | 09/27/2011 |
Product Code |
NKF |
Advisory Committee |
Pathology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF A STRAINER TYPE BARRIER TO THE CURRENT DAB DISPENSER RETAINER DESIGN, COLORIZATION OF STOP BARREL, AND ASSEMBLY EQUIPMENT UPDATES TO ACCOMMODATE THE MODIFIED RETAINER. |
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