PMA
P230011: TruSight Oncology Comprehensive
FDA PMA · Next generation sequencing oncology panel, somatic or germline variant detection system · Illumina, Inc.
Key facts
| PMA number | P230011 |
|---|---|
| Trade name | TruSight Oncology Comprehensive |
| Generic name | Next generation sequencing oncology panel, somatic or germline variant detection system |
| Applicant | Illumina, Inc. |
| Owner/operator | Illumina, Inc. |
| Product code | PQP |
| Approval date | Aug 21, 2024 |
| Establishment registration | 3003218906 |
| FEI number | 3003218906 |
At a glance
- 1–9 Supplements
- Sep 4, 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- No Withdrawn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: