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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.
Classification Namesystem, test, her-2/neu, nucleic acid or serum
Generic Nameneu gene assay kit
PMA NumberP980024
Date Received06/16/1998
Decision Date12/11/1998
Product Code
MVD[ Registered Establishments with MVD ]
Docket Number 99M-0034
Notice Date 01/20/1999
Advisory Committee Immunology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the pathyvysion(tm) her-2 dna probe kit. The pathyvysion(tm) her-2 dna probe kit (pathyvysion kit) is designed to detect amplification ofthe her-2/neu gene via fluorescence in situ hybridization (fish) in formalin-fixed paraffin-embedded human breast cancer tissue speciments. Results from the pathvysion kit are intended for use as an adjuncto to existing clinical and pathologic information currently used as prognostic factors in state ii, node-positive breast cancer patients. The pathvysion kit is further indicated as an aid in predct disease-free and overall survival in patients with stage ii, node positive breast cancer treated with adjuvant cyclophosphamide, dosorubicin, and 5-fluorouracil (caf) chemotherapy.
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012