This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
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.
| Device | GENESEARCH BREAST LYMPH NODE(BLN) ASSAY |
| Generic Name | Rt-pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection |
| Applicant | JANSSEN DIAGNOSTICS |
| Date Received | 2006-05-01 |
| Decision Date | 2007-07-16 |
| Notice Date | 2007-11-09 |
| PMA | P060017 |
| Supplement | S |
| Product Code | OCB |
| Docket Number | 07M-0413 |
| Advisory Committee | Pathology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | JANSSEN DIAGNOSTICS 700 Us Highway Rte 202 South raritan, NJ 08869 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P060017 | Original Filing | |
| S004 | 2009-11-19 | 30-day Notice |
| S003 | 2009-03-02 | Normal 180 Day Track No User Fee |
| S002 | ||
| S001 | 2007-08-15 | Normal 180 Day Track No User Fee |