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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.
 
DeviceRoche cobas EGFR Mutation Test, Roche cobas® DNA Sample Preparation Kit, cobas® EGFR Mutation Test v2, Roche cobas® cfD
Generic NameSomatic gene mutation detection system
ApplicantROCHE
4300 HACIENDA DRIVE
PO BOX 9002
PLEASANTON, CA 94588
PMA NumberP120019
Supplement NumberS035
Date Received07/20/2023
Decision Date08/17/2023
Product Code OWD 
Advisory Committee Pathology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Elimination of redundant in-process testing.
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