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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
ApplicantRoche
4300 Hacienda Dr.
P.O. Box 9002
Peasanton, CA 94588
PMA NumberP120019
Supplement NumberS029
Date Received06/27/2019
Decision Date09/25/2019
Product Code OWD 
Advisory Committee Pathology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a formulation change to the cobas® DNA Sample Preparation Kit used with the cobas® EGFR Mutation Test for plasma and tissues specimens.
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