Shield
FDA premarket approval P230009/S006 · decided 2025-04-28
Approval details
- PMA number
- P230009
- Supplement
- S006
- 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
- 2025-04-01
- Decision date
- 2025-04-28
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- PHP
- Advisory committee
- Medical Genetics
- Expedited review
- No
- Location
- Palo Alto, CA
- Statement
- approval of a secondary supplier of critical raw materials, scale-up of the manufacturing process for a device component, and expansion of QC testing facilities at an existing site
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