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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 (BLN) 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 NumberS004
Date Received11/19/2009
Decision Date12/17/2009
Withdrawal Date 03/30/2015
Product Code OCB 
Advisory Committee Pathology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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.
Post-Approval StudyShow Report Schedule and Study Progress
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