PMA P230009S009
- Device
- Shield
- Applicant
- Guardant Health, Inc.
- PMA number
- P230009
- Supplement
- S009
- Product code
- PHP
- Decision date
- 2025-10-30
- Classification
- Medical Genetics
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Approval order statement
- approval for addition of a secondary vendor and manufacturing process changes
Current openFDA PMA Record#
- Device
- Shield
- Applicant
- Guardant Health, Inc.
- PMA number
- P230009
- Supplement
- S009
- Product code
- PHP
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Decision date
- 2025-10-30
- Decision code
- OK30
- Date received
- 2025-09-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for addition of a secondary vendor and manufacturing process changes