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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: 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.
 
DeviceGENESEARCH BREAST LYMPH NODE ASSAY
Generic NameRT-PCR multigene expression test, sentinel lymph node, cancer metastasis detection
ApplicantJANSSEN DIAGNOSTICS
700 US HIGHWAY RTE 202 SOUTH
RARITAN, NJ 08869
PMA NumberP060017
Supplement NumberS003
Date Received03/02/2009
Decision Date07/09/2009
Withdrawal Date 03/30/2015
Product Code OCB 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order 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.
Post-Approval StudyShow Report Schedule and Study Progress
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