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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 Nameerbb2 gene amplification kit
PMA NumberP040005
Supplement NumberS006
Date Received12/05/2011
Decision Date06/08/2012
Product Code
MVD[ Registered Establishments with MVD ]
Advisory Committee Pathology
Clinical Trials NCT00567190
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for addition of pertuzumab in the labeling of her2 fish pharmdx kit. The device, as modified, will be marketed under the trade name her2 fish pharmdx kit and its indication for use is: a direct fluorescence in situ hybridization (fish) assay designed to quantitatively determine her2 gene amplification in formalin-fixed, paraffin-embedded (ffpe) breast cancer tissue specimens and ffpe specimens from patients with metastatic gastric or gastroesophageal junction adenocarcinoma. Her2 fish pharmdx kit is indicated as an aid in the assessment of breast and gastric cancer patients for whom herceptin (trastuzumab) treatment is being considered and for breast cancer patients for whom perjeta (pertuzumab) treatment is being considered (see herceptin and perjeta package inserts).