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. |
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Device | HER2 FISH PHARMADX KIT |
Generic Name | system, test, her-2/neu, nucleic acid or serum |
Applicant |
Agilent Technologies Singapore (International) Pte Ltd. |
no. 1 yishun avenue 7 |
singapore 76892 |
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PMA Number | P040005 |
Supplement Number | S009 |
Date Received | 08/24/2012 |
Decision Date | 02/22/2013 |
Product Code |
MVD
|
Advisory Committee |
Pathology |
Supplement Type | normal 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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