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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
Generic Namesystem, test, her-2/neu, nucleic acid or serum
1300 east touhy avenue
des plaines, IL 60018
PMA NumberP980024
Date Received06/16/1998
Decision Date12/11/1998
Product Code MVD 
Docket Number 99M-0034
Notice Date 01/20/1999
Advisory Committee Pathology
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:  S014 S015 S003 S012 S011 S010 S013 S009 
S004 S002 S001 S008 S007 S006 S005 S021 S019 
S020 S018 S017 S016