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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.
 
Trade NameGENESEARCH BREAST LYMPH NODE ASSAY
Classification Namert-pcr multigene expression test, sentinel lymph node, cancer metastasis detection
Generic Namegenesearch bln assay
ApplicantVERIDEX, LLC
PMA NumberP060017
Supplement NumberS003
Date Received03/02/2009
Decision Date07/09/2009
Product Code
OCB[ Registered Establishments with OCB ]
Advisory Committee Immunology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
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.
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