PMA
P210040: RESOLUTION ctDx FIRST
FDA PMA · Next generation sequencing oncology panel, somatic or germline variant detection system · Exact Sciences Corporation
Key facts
| PMA number | P210040 |
|---|---|
| Trade name | RESOLUTION ctDx FIRST |
| Generic name | Next generation sequencing oncology panel, somatic or germline variant detection system |
| Applicant | Exact Sciences Corporation |
| Product code | PQP |
| Approval date | Dec 12, 2022 |
| Docket number | 22M-3219 |
| FEI number | 3017476300 |
At a glance
- 1–9 Supplements
- Jul 27, 2023 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- No Withdrawn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: