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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.
 
DeviceShield
Generic NameSystem, colorectal neoplasia, DNA methylation and hemoglobin detection
ApplicantGuardant Health, Inc.
3000 Hanover St.
Palo Alto, CA 94304
PMA NumberP230009
Supplement NumberS020
Date Received08/21/2026
Decision Date09/16/2026
Product Code PHP 
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  
manufacturing changes
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