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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.
Devicecobas EGFR Mutation Test v2
Generic NameSomatic gene mutation detection system
PO BOX 9002
PMA NumberP120019
Supplement NumberS031
Date Received04/30/2020
Decision Date10/27/2020
Product Code OWD 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for cobas® EGFR Mutation Test v2 label expansion to obtain companion diagnostic group labeling claim for EGFR Tyrosine Kinase Inhibitors (TKI) for specific EGFR mutations detected by the test.