| Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device. |
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| Trade Name | PATHWAY ANTI-HER-2/NEU |
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| Classification Name | system, test, her-2/neu, ihc |
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| Generic Name | mouse monoclonal antibody for aid in the detection of c-eerbb-2 antigen in histological tissue section |
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| Applicant | VENTANA MEDICAL SYSTEMS, INC. |
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| PMA Number | P990081 |
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| Supplement Number | S007 |
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| Date Received | 11/19/2007 |
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| Decision Date | 12/12/2007 |
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| Product Code | |
| Advisory Committee |
Immunology |
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| Supplement Type | 30-day notice |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Change in the raw material used to manufacture cell line multiblocks to eliminate background staining of the control slides. |
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