Shield
FDA premarket approval P230009/S009 · decided 2025-10-30
Approval details
- PMA number
- P230009
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Shield
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Applicant
- Guardant Health, Inc.
- Date received
- 2025-09-30
- Decision date
- 2025-10-30
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- PHP
- Advisory committee
- Medical Genetics
- Expedited review
- No
- Location
- Palo Alto, CA
- Statement
- approval for addition of a secondary vendor and manufacturing process changes
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