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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.
 
DeviceMI Cancer Seek
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantCaris Life Sciences
4610 S. 44th Pl.
Phoenix, AZ 85040
PMA NumberP240010
Supplement NumberS005
Date Received05/19/2025
Decision Date06/18/2025
Product Code PQP 
Advisory Committee Molecular Genetics
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for changes to the equipment validation acceptance criteria for the qualification of serial number-controlled instruments
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