|
Device | GENESEARCH BREAST LYMPH NODE (BLN) ASSAY |
Generic Name | RT-PCR multigene expression test, sentinel lymph node, cancer metastasis detection |
Applicant | JANSSEN DIAGNOSTICS 700 US HIGHWAY RTE 202 SOUTH RARITAN, NJ 08869 |
PMA Number | P060017 |
Supplement Number | S004 |
Date Received | 11/19/2009 |
Decision Date | 12/17/2009 |
Withdrawal Date
|
03/30/2015 |
Product Code |
OCB |
Advisory Committee |
Pathology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement EXTENSION OF SHELF-LIFE OF PLASMID DNA RAW MATERIAL USED IN THE MANUFACTURE OF THE EXTERNAL POSITIVE AND EXTERNAL NEGATIVE CONTROLS OF THE DEVICE. |