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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 NameHER2 FISH PHARMADX KIT
Classification Namesystem, test, her-2/neu, nucleic acid or serum
Generic Nameerbb2 gene amplification kit
ApplicantDAKO DENMARK A/S
PMA NumberP040005
Supplement NumberS009
Date Received08/24/2012
Decision Date02/22/2013
Product Code
MVD[ Registered Establishments with MVD ]
Advisory Committee Pathology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for addition of kadcyla (ado-trastuzumab emtansine) in the labeling of her2 iq-fish pharmdx kit.
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