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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
Classification Namert-pcr multigene expression test, sentinel lymph node, cancer metastasis detection
Generic Namegenesearch bln assay
ApplicantVERIDEX, LLC
PMA NumberP060017
Supplement NumberS001
Date Received08/15/2007
Decision Date10/23/2007
Product Code
OCB[ Registered Establishments with OCB ]
Advisory Committee Immunology
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the post-approval study.
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