PMA
P160038: Praxis Extended RAS Panel
FDA PMA · Next generation sequencing oncology panel, somatic or germline variant detection system · Illumina, Inc.
Key facts
| PMA number | P160038 |
|---|---|
| Trade name | Praxis Extended RAS Panel |
| 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 | Jun 29, 2017 |
| Docket number | 17M-3983 |
| Notice date | Jun 30, 2017 |
| Establishment registration | 3003218906 |
| FEI number | 3003218906 |
At a glance
- 10–99 Supplements
- Feb 17, 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- No Withdrawn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: