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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.
DevicePraxis Extended RAS Panel
Generic Namenext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantIllumina, Inc.
5200 illumina way
san diego, CA 92122
PMA NumberP160038
Supplement NumberS004
Date Received06/01/2018
Decision Date06/25/2018
Product Code PQP 
Advisory Committee Pathology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Redesign of Quality Control method that tests for cross-contamination and purity of Index Adapters which will include the obsolescence of Illumina’s Genome Analyzer IIx.