Shield
FDA premarket approval P230009/S001 · decided 2024-09-20
Approval details
- PMA number
- P230009
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Shield
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Applicant
- Guardant Health, Inc.
- Date received
- 2024-08-23
- Decision date
- 2024-09-20
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- PHP
- Advisory committee
- Medical Genetics
- Expedited review
- No
- Location
- Palo Alto, CA
- Statement
- approval of the protocol for the post-approval study (PAS)
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