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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 NumberS002
Date Received03/05/2018
Decision Date03/26/2018
Withdrawal Date12/22/2023
Product Code PQP 
Advisory Committee Pathology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the implementation of 100% visual volume inspection of the filled containers.
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