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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namert-pcr multigene expression test, sentinel lymph node, cancer metastasis detection
Generic Namegenesearch bln assay
PMA NumberP060017
Supplement NumberS004
Date Received11/19/2009
Decision Date12/17/2009
Product Code
OCB[ Registered Establishments with OCB ]
Advisory Committee Pathology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
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.