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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.
 
Trade NameHERCEP TEST
Classification Namesystem, test, her-2/neu, ihc
Generic Namedako anti-her2 ihc system
ApplicantDAKO CYTOMATION DENMARK A/S
PMA NumberP980018
Supplement NumberS015
Date Received12/05/2011
Decision Date06/08/2012
Product Code
MVC[ Registered Establishments with MVC ]
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 herceptest. The device, as modified, will be marketed under the trade name herceptest and its indication for use is: herceptest is a semi-quantitative immunohisto-chemical assay to determine her2 protein overexpression in breast cancer tissues routinely processed for histological evaluation and formalin-fixed, paraffin-embedded cancer tissue from patients with metastatic gastric or gastroesophageal junction adenocarcinoma. Herceptest 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).
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