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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
Generic NameSYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
ApplicantAgilent Technologies Singapore (International) Pte , Ltd.
# 1 Yishun Ave. 7
Singapore 76892
PMA NumberP040005
Supplement NumberS009
Date Received08/24/2012
Decision Date02/22/2013
Product Code MVD 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR ADDITION OF KADCYLA (ADO-TRASTUZUMAB EMTANSINE) IN THE LABELING OF HER2 IQ-FISH PHARMDX KIT.
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