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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 and Cobas EGFR Mutation Test v2
Generic NameSomatic gene mutation detection system
ApplicantRoche
4300 Hacienda Dr.
P.O. Box 9002
Peasanton, CA 94588
PMA NumberP120019
Supplement NumberS020
Date Received03/01/2018
Decision Date03/27/2018
Product Code OWD 
Advisory Committee Pathology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Modification of manufacturing fill line processes
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