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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.
 
DeviceOncomine Dx Target Test
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantLife Technologies Corporation
5781 Van Allen Way
Carlsbad, CA 92008
PMA NumberP160045
Supplement NumberS045
Date Received12/20/2023
Decision Date06/17/2024
Product Code PQP 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to update the user guide and promotional materials for the Oncomine Dx Target Test to include the results of the study data as recommended by FDA in P160045/R011, P160045/R017, P160045/R018, P160045/R025, P160045/R028, P160045/R030, and P160045/R031.
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