| Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device. |
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| Trade Name | GENESEARCH BREAST LYMPH NODE(BLN) ASSAY |
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| Classification Name | rt-pcr multigene expression test, sentinel lymph node, cancer metastasis detection |
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| Generic Name | genesearch bln assay |
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| Applicant | VERIDEX, LLC |
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| PMA Number | P060017 |
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| Date Received | 05/01/2006 |
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| Decision Date | 07/16/2007 |
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| Product Code | |
| Docket Number | 07M-0413 |
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| Notice Date | 11/09/2007 |
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| Advisory Committee |
Immunology |
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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 genesearch breast lymph node (bln) assay. This device is indicated as a qualitative, in vitro diagnostic test for the rapid detection of greater than 0. 2 mm metastases in nodal tissue removed from sentinel lymph node biopsies of breast cancer patients. Results from the assay can be used to guide the intra operative or post-operative decision to remove additional lymph nodes. Post-operative histological evaluation of permanent sections of the tissue specimen, in accordance with usual diagnostic practice and using the veridex lymph node cutting scheme, is required. |
| Approval Order |
Approval Order
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| Post-Approval Study | Show Report Schedule and Study Progress |
| Supplements: |
S001 S003 S004 |
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