GENESEARCH BREAST LYMPH NODE ASSAY
FDA premarket approval P060017/S003 · decided 2009-07-09
Approval details
- PMA number
- P060017
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GENESEARCH BREAST LYMPH NODE ASSAY
- Generic name
- RT-PCR multigene expression test, sentinel lymph node, cancer metastasis detection
- Applicant
- Janssen Diagnostics
- Date received
- 2009-03-02
- Decision date
- 2009-07-09
- Days to decision
- 129 days
- Decision code
- APPR
- Product code
- OCB
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- APPROVAL FOR: 1) A MANUFACTURING SITE LOCATED AT VERIDEX, LLC IN WARREN, NEW JERSEY; 2) THE ADDITION OF A SECOND EXISTING SITE; AND 3) A CHANGE IN RAW MATERIAL SPECIFICATIONS.
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