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.
Extension of shelf-life of plasmid dna raw material used in the manufacture of the external positive and external negative controls of the device.
| 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 | 2009-11-19 |
| Decision Date | 2009-12-17 |
| PMA | P060017 |
| Supplement | S004 |
| Product Code | OCB |
| Advisory Committee | Pathology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | JANSSEN DIAGNOSTICS 700 Us Highway Rte 202 South raritan, NJ 08869 |
| 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 |