PMA P230009S014
- Device
- Shield
- Applicant
- Guardant Health, Inc.
- PMA number
- P230009
- Supplement
- S014
- Product code
- PHP
- Decision date
- 2026-04-15
- Classification
- Medical Genetics
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Approval order statement
- This submission is approved. Sponsor has responded to all the questions raised by FDA.
Current openFDA PMA Record#
- Device
- Shield
- Applicant
- Guardant Health, Inc.
- PMA number
- P230009
- Supplement
- S014
- Product code
- PHP
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Decision date
- 2026-04-15
- Decision code
- APPR
- Date received
- 2026-02-17
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- This submission is approved. Sponsor has responded to all the questions raised by FDA.