PMA supplement
P060017 S004: GENESEARCH BREAST LYMPH NODE (BLN) ASSAY
FDA PMA supplement · 30-Day Notice · Janssen Diagnostics
Key facts
| Original PMA | P060017 |
|---|---|
| Supplement number | S004 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | GENESEARCH BREAST LYMPH NODE (BLN) ASSAY |
| Generic name | RT-PCR multigene expression test, sentinel lymph node, cancer metastasis detection |
| Applicant | Janssen Diagnostics |
| Product code | OCB |
| Received date | Nov 19, 2009 |
| Decision date | Dec 17, 2009 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: