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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® EZH2 Mutation Test
Generic NameSomatic gene mutation detection system
ApplicantRoche Molecular System, Inc.
4300 Hacienda Drive
Pleasanton, CA 94588
PMA NumberP200014
Supplement NumberS003
Date Received02/22/2021
Decision Date08/10/2021
Product Code OWD 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the revised Instructions for Use for the cobas® EZH2 Mutation Test.
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