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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 NumberS011
Date Received03/25/2019
Decision Date06/19/2019
Product Code PQP 
Advisory Committee Pathology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a manufacturing site located at Illumina, Inc., 5200 Illumina Way, San Diego, CA 92122.