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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.
 
DeviceAgilent Resolution ctDx FIRST
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantExact Sciences Corporation
5505 Endeavor Ln.
Madision, WI 53719
PMA NumberP210040
Supplement NumberS001
Date Received06/27/2023
Decision Date07/27/2023
Withdrawal Date06/05/2025
Product Code PQP 
Advisory Committee Molecular Genetics
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for modifications to the Instructions for Use for the Agilent Resolution Sample Collection Kit, a component of the Agilent Resolution ctDx FIRST assay
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