Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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 NumberS010
Date Received11/14/2025
Decision Date07/22/2026
Product Code PHP 
Advisory Committee Molecular Genetics
Clinical TrialsNCT04136002
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a change to the Shield EP1 classification model which streamlines Guardant Shield to a methylation-only workflow, removing fragmentomic and somatic components.
-
-