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 | HERCAP TEST |
Generic Name | system, test, her-2/neu, ihc |
Applicant | Agilent Technologies Singapore (International) Pte Ltd. no. 1 yishun avenue 7 singapore 76892 |
PMA Number | P980018 |
Supplement Number | S016 |
Date Received | 08/24/2012 |
Decision Date | 02/22/2013 |
Product Code |
MVC |
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 HERCEP TEST ¿. |
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