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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 NumberS019
Date Received12/30/2020
Decision Date07/29/2021
Withdrawal Date12/22/2023
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site located at Illumina Singapore, 29 Woodlands Industrial Park E1, Singapore, South East 757716, for manufacturing of MiSeqDx Cartridge and MiSeqDx Flow Cell.
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