PMA
P200010: Guardant360 CDx
FDA PMA · Next generation sequencing oncology panel, somatic or germline variant detection system · Guardant Health, Inc.
Key facts
| PMA number | P200010 |
|---|---|
| Trade name | Guardant360 CDx |
| Generic name | Next generation sequencing oncology panel, somatic or germline variant detection system |
| Applicant | Guardant Health, Inc. |
| Owner/operator | Guardant Health, Inc |
| Product code | PQP |
| Approval date | Aug 7, 2020 |
| Docket number | 20M-1748 |
| Notice date | Aug 28, 2020 |
| Establishment registration | 3012090384 |
| FEI number | 3012090384 |
At a glance
- 10–99 Supplements
- Sep 18, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: