PMA
P230009: Shield
FDA PMA · System, colorectal neoplasia, DNA methylation and hemoglobin detection · Guardant Health, Inc.
Key facts
| PMA number | P230009 |
|---|---|
| Trade name | Shield |
| Generic name | System, colorectal neoplasia, DNA methylation and hemoglobin detection |
| Applicant | Guardant Health, Inc. |
| Owner/operator | Guardant Health, Inc |
| Product code | PHP |
| Approval date | Jul 26, 2024 |
| Establishment registration | 3012090384 |
| FEI number | 3012090384 |
At a glance
- 10–99 Supplements
- Oct 5, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: