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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 Namesystem, test, her-2/neu, nucleic acid or serum
Generic Namesystem, test, her-2/neu, nucleic acid or serum
1300 east touhy avenue
des plaines, IL 60018
PMA NumberP980024
Supplement NumberS001
Date Received03/30/2001
Decision Date12/31/2001
Product Code
MVD[ Registered Establishments with MVD ]
Docket Number 02M-0172
Notice Date 04/25/2002
Advisory Committee Pathology
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the pathvysion her-2 dna probe kit. This device is indicated to detect amplification of the her-2/neu gene via fluorescence in situ hybridization (fish) in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Results from the pathvysion kit are intended for use as an adjunct to existing clinical and pathologic information currently used as prognostic factors in stage ii, node-positive breast cancer patients. The pathvysion kit is further indicated as an aid to predict disease-free and overall survival in patients with stage ii, node positive breast cancer treated with adjuvant cyclophosphamide, doxorubicin, and 5-fluorouracil (caf) chemotherapy. The pathvysion kit is indicated as an aid in the assessment of patients for whom herceptin (trastuzumab) treatment is being considered (see herceptin package insert).
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling