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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 NumberS001
Date Received08/15/2007
Decision Date10/23/2007
Product Code
OCB[ Registered Establishments with OCB ]
Advisory Committee Pathology
Supplement Typenormal 180 day track no user fee
Supplement Reason pas protocal supplement osb
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the post-approval study.