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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameGENESEARCH BREAST LYMPH NODE(BLN) ASSAY
Classification Namert-pcr multigene expression test, sentinel lymph node, cancer metastasis detection
Generic Namegenesearch bln assay
ApplicantVERIDEX, LLC
PMA NumberP060017
Date Received05/01/2006
Decision Date07/16/2007
Product Code
OCB[ Registered Establishments with OCB ]
Docket Number 07M-0413
Notice Date 11/09/2007
Advisory Committee Pathology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the genesearch breast lymph node (bln) assay. This device is indicated as a qualitative, in vitro diagnostic test for the rapid detection of greater than 0. 2 mm metastases in nodal tissue removed from sentinel lymph node biopsies of breast cancer patients. Results from the assay can be used to guide the intra operative or post-operative decision to remove additional lymph nodes. Post-operative histological evaluation of permanent sections of the tissue specimen, in accordance with usual diagnostic practice and using the veridex lymph node cutting scheme, is required.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S003 S004 
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