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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceHER2 FISH PHARMADX KIT
Classification Namesystem, test, her-2/neu, nucleic acid or serum
Generic Namesystem, test, her-2/neu, nucleic acid or serum
Applicant
DAKO DENMARK A/S
42 produktionsvej
2600 glostrup DK-26-2600
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/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR ADDITION OF KADCYLA (ADO-TRASTUZUMAB EMTANSINE) IN THE LABELING OF HER2 IQ-FISH PHARMDX KIT.
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