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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.
Generic Namesomatic gene mutation detection system
ApplicantbioMerieux, Inc.
595 anglum rd.
hazelwood, MO 63042
PMA NumberP120014
Supplement NumberS006
Date Received01/11/2016
Decision Date04/05/2016
Product Code OWD 
Advisory Committee Pathology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a change in the THxID-BRAF software to detect a specific fallback threshold value within the SDS file and in such case prevent the generation of a mutation report.