| 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 | PATHVYSION HER-2 DNA PROBE KIT |
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| Classification Name | system, test, her-2/neu, nucleic acid or serum |
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| Generic Name | neu gene assay kit |
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| Applicant | VYSIS |
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| PMA Number | P980024 |
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| Supplement Number | S001 |
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| Date Received | 03/30/2001 |
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| Decision Date | 12/31/2001 |
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| Product Code | |
| Docket Number | 02M-0172 |
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| Notice Date | 04/25/2002 |
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| Advisory Committee |
Immunology |
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| Supplement Type | panel track |
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| Supplement Reason | labeling change - indications |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
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Approval Order Statement
Approval for the pathvysion her-2 dna probe kit. This device is indicated to detect amplification of the her-2/neu gene via fluorescence in situ hybridization (fish) in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Results from the pathvysion kit are intended for use as an adjunct to existing clinical and pathologic information currently used as prognostic factors in stage ii, node-positive breast cancer patients. The pathvysion kit is further indicated as an aid to predict disease-free and overall survival in patients with stage ii, node positive breast cancer treated with adjuvant cyclophosphamide, doxorubicin, and 5-fluorouracil (caf) chemotherapy. The pathvysion kit is indicated as an aid in the assessment of patients for whom herceptin (trastuzumab) treatment is being considered (see herceptin package insert). |
| Approval Order |
Approval Order
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